NCT02474160ClinicalTrials.gov

Collection and Storage of Tissue and Blood Samples From Patients With Cancer

Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

This study collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn…

Observationnelle5 000 participants recherchés140 sites1 pays

Catégories

Oncologie100%

Enregistré dans 1 registre

ClinicalTrials.govNCT02474160Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Not stated: Registered after enrolment began (about 29 days after the recorded start)First posted 2015-06-17; recorded start 2015-05-19
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (National Cancer Institute LAO)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 4 conditions.
Lead sponsor type recorded as: not stated in the registry record.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Masking not stated in the record
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 140 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration3/5
Registered within 30 days of the study start
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study: 5,000 participants (target), run at 140 sites.

How this score is built

Enrolment36/40
5,000 participants (target)
Site count24/25
140 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 133 months
Sponsor scale1/10
National Cancer Institute LAO has led 2 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

PRIMARY OBJECTIVE: I. To procure biologic tissues and materials to generate preclinical models of cancer. OUTLINE: This is an observational study. Tumor tissue and blood samples are procured during procedures that are required for the patients' clinical management and will be stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis.

Affections

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Malignant Solid Neoplasm

Éligibilité

Éligibilité
Sexe	Tous
Âges	2 Months – Aucun maximum
Volontaires sains	Non
Méthode d'échantillonnage	NON_PROBABILITY_SAMPLE

Population de l'étude

Patients undergoing evaluation and/or treatment for cancer

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: * Patients older than 2 months of age who are being evaluated, treated, or enrolled in a clinical trial for cancer at participating sites * Patients with a histologically or cytologically confirmed diagnosis of cancer * Patients without histologically or cytologically confirmed diagnosis of cancer, but for whom approval has been requested and received from the coordinating site study coordinator * Requests for coordinating site approval should only be made if the patient's existing work-up at the time of the request demonstrates a combination of two or more of the following indicating the greater likelihood of a cancerous process in the assessment of the treating physician: * Radiographic imaging (computed tomography \[CT\], magnetic resonance imaging \[MRI\], etc.) * Elevated tumor markers * Clinical symptoms * Documented risk factors, known genetic changes (mutation, deletion, fusion, etc.), and/or known familial cancer history or syndrome * Complete blood count (CBC) w/differential indicative of a probable hematologic malignancy * If the patient will be undergoing surgical resection at a later time and will be accessible to approach for study participation at that time, resected material following cancer diagnosis confirmation is preferred * Important: Additional medical, genetic and/or demographic work-up should not be obtained solely for determination of eligibility for protocol 9846 by these criteria. Once available, final histology must be confirmed to the coordinating site detailing the cancer diagnosis for patients enrolled based on the above criteria * Patients with a newly diagnosed primary and/or metastatic solid tumor or hematologic malignancy for which they have not yet received treatment * Patients with a solid tumor or hematologic malignancy that is recurrent, newly metastasized, or progressing while on treatment indicated by: * Radiographic evidence of tumor growth, re-growth, and/or new metastases, OR * Documentation by the treating physician of clinical disease progression, OR * CBC w/differential and/or flow cytometry for hematologic malignancies * Patients currently undergoing treatment (adjuvant, neoadjuvant, etc.) * Specimen collection should occur as distant in time from the most recent drug administration as possible (e.g., after completion of a treatment cycle and immediately prior to initiation of the next cycle) * Specimens should not be collected from patients between doses within a single treatment cycle * Confirmation of viable residual malignancy and/or \< 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the National Cancer Institute (NCI) coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report * Patients with ongoing partial response (PR) or stable disease (SD) are eligible * Confirmation of viable malignancy and/or \< 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the NCI coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report * Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol * For pediatric patients, ability and willingness to assent to participation, using an explanation that is understandable/age appropriate, as well as receiving parental permission. Signature requirements for pediatric patients can be adjusted based on local guidelines Exclusion Criteria: * Patients with cancer-like syndromes and/or blood disorders such as systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia/hypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS) * Patients with invasive fungal infections * Patients with active and/or uncontrolled bacterial, fungal, or viral infections or who are still recovering from an infection * Actively febrile patients with uncertain etiology of febrile episode * All antibiotics prescribed for the treatment of a bacterial infection should be completed at least 1 week (7 days) prior to collection * Patients with a hematologic malignancy who are treated with an antibiotic, anti-fungal, and/or anti-viral medication for an active infection who then remain on the treatment for prophylaxis following resolution of the infection as assessed by the treating physician are not excluded * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics * Patients receiving antibiotics, antifungals, and/or antivirals for prophylaxis are permissible * Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible * Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e., quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]) or known history of HCV, HBV, or HIV; testing for HBV, HCV, HIV or other infections for eligibility will be performed only if clinically indicated * Patients with hepatitis A as indicated by anti-hepatitis A virus (HAV) IgM reactivity * Patients that are anti-HAV IgG reactive only are eligible * Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR)

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Observationnelle
Phase	Non précisé dans la fiche du registre
Répartition	Non précisé dans la fiche du registre
Modèle d'intervention	Non précisé dans la fiche du registre
Objectif principal	Non précisé dans la fiche du registre
Insu	Non précisé dans la fiche du registre
Recrutement	5 000 participants recherchés

Promoteur et collaborateurs

National Cancer Institute LAO Promoteur
National Cancer Institute (NCI) Collaborateurs

Groupes et interventions

Observational (tissue and blood procurement)
Tumor tissue and blood samples are procured during procedures that are required for the patients' clinical management and stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis.

Interventions

Autre Cytology Specimen Collection Procedure
Procurement of tissue and blood samples

Critères de jugement

Critère de jugement principal
Procurement of tissue and blood specimens for research purposes
Tissues and venous blood will be stored, implanted immediately to generate patient-derived xenografts (which require fresh, viable cells), or placed immediately into in vitro cell culture to generate patient-derived cell lines (which require fresh, viable cells).
Délai Up to 5 years

Dates

Dates
Date de début	19 mai 2015 (réelle)
Achèvement principal	4 mai 2026 (estimée)
Achèvement	4 mai 2026 (estimée)
Première publication	17 juin 2015 (estimée)
Dernière mise à jour	5 mars 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	mars 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

22 sites sont en recrutement

United States

United States
Établissement	Ville	État ou région	Statut
Trinity Health Saint Joseph Mercy Hospital Ann Arbor	Ann Arbor	Michigan	Actif, sans recrutement
PCR Oncology	Arroyo Grande	California	Actif, sans recrutement
MultiCare Auburn Medical Center	Auburn	Washington	Actif, sans recrutement
Augusta University Medical Center	Augusta	Georgia	En recrutement
UCHealth University of Colorado Hospital	Aurora	Colorado	Actif, sans recrutement
Virginia Mason Bainbridge Island Medical Center	Bainbridge Island	Washington	Actif, sans recrutement
Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	Actif, sans recrutement
Bronson Battle Creek	Battle Creek	Michigan	Suspendu
University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	Suspendu
OSF Saint Joseph Medical Center	Bloomington	Illinois	Actif, sans recrutement
Illinois CancerCare-Bloomington	Bloomington	Illinois	Suspendu
Central Care Cancer Center - Bolivar	Bolivar	Missouri	Suspendu
Parkland Health Center-Bonne Terre	Bonne Terre	Missouri	Suspendu
Dana-Farber Cancer Institute	Boston	Massachusetts	Actif, sans recrutement
Cox Cancer Center Branson	Branson	Missouri	Suspendu
Illinois CancerCare-Canton	Canton	Illinois	Suspendu
Saint Francis Medical Center	Cape Girardeau	Missouri	Suspendu
Southeast Cancer Center	Cape Girardeau	Missouri	Suspendu
Memorial Hospital of Carbondale	Carbondale	Illinois	Suspendu
Illinois CancerCare-Carthage	Carthage	Illinois	Suspendu
Centralia Oncology Clinic	Centralia	Illinois	Suspendu
Cancer Center of Kansas - Chanute	Chanute	Kansas	Suspendu
UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	Suspendu
John H Stroger Jr Hospital of Cook County	Chicago	Illinois	En recrutement
Marshfield Clinic-Chippewa Center	Chippewa Falls	Wisconsin	Actif, sans recrutement
Decatur Memorial Hospital	Decatur	Illinois	En recrutement
Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois	En recrutement
Cancer Center of Kansas - Dodge City	Dodge City	Kansas	Suspendu
City of Hope Comprehensive Cancer Center	Duarte	California	Actif, sans recrutement
Duke University Medical Center	Durham	North Carolina	Actif, sans recrutement
Marshfield Clinic Cancer Center at Sacred Heart	Eau Claire	Wisconsin	Actif, sans recrutement
Crossroads Cancer Center	Effingham	Illinois	Suspendu
Cancer Center of Kansas - El Dorado	El Dorado	Kansas	Suspendu
Illinois CancerCare-Eureka	Eureka	Illinois	Suspendu
Virginia Mason Federal Way Medical Center	Federal Way	Washington	Actif, sans recrutement
Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	Suspendu
Mercy Hospital Fort Smith	Fort Smith	Arkansas	En recrutement
Western Illinois Cancer Treatment Center	Galesburg	Illinois	Suspendu
Illinois CancerCare-Galesburg	Galesburg	Illinois	Suspendu
MultiCare Gig Harbor Medical Park	Gig Harbor	Washington	Actif, sans recrutement
Corewell Health Grand Rapids Hospitals - Butterworth Hospital	Grand Rapids	Michigan	En recrutement
Trinity Health Grand Rapids Hospital	Grand Rapids	Michigan	Suspendu
Cancer and Blood Specialists-Henderson	Henderson	Nevada	Actif, sans recrutement
M D Anderson Cancer Center	Houston	Texas	Actif, sans recrutement
Cancer Center of Kansas-Independence	Independence	Kansas	Suspendu
MU Health Care Goldschmidt Cancer Center	Jefferson City	Missouri	Suspendu
Mercy Hospital Joplin	Joplin	Missouri	En recrutement
Freeman Health System	Joplin	Missouri	En recrutement
Ascension Borgess Hospital	Kalamazoo	Michigan	Suspendu
West Michigan Cancer Center	Kalamazoo	Michigan	Suspendu

90 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT02474160