A Multicenter Cancer Biospecimen Collection Study

NCT ID: NCT04510129

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-05

Study Completion Date

2027-02-28

Brief Summary

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This study will collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. These specimens and clinical data may be used in subsequent studies for the development and validation of a diagnostic test.

Detailed Description

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This study will establish a prospective cohort of pre-treatment tumor specimens with correlated de-identified clinical and demographic data and tissue histology from cancer patients who are undergoing treatment with PD-1/PD-L1 inhibitors. Patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled.

The study will not require a study-specific tumor biopsy; any biopsies taken prior to treatment as part of standard of care are eligible for this study. Biopsies must not have been taken after immunotherapy treatment began.

Participants will be asked to provide their consent for the potential use of their biospecimens in subsequent studies for the development and validation of a diagnostic test.

Conditions

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Cancer of Head and Neck Lung Cancer, Nonsmall Cell Small-cell Lung Cancer Urothelial Carcinoma Gastroesophageal Junction Adenocarcinoma Cervical Cancer Esophageal Squamous Cell Carcinoma Triple Negative Breast Cancer Hepatocellular Carcinoma Renal Cell Carcinoma Colorectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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head and neck squamous cell carcinoma (HNSCC)

OncoPrism™ assay

Intervention Type DIAGNOSTIC_TEST

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

non-small-cell lung cancer (NSCLC)

OncoPrism™ assay

Intervention Type DIAGNOSTIC_TEST

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

small cell lung cancer (SCLC)

OncoPrism™ assay

Intervention Type DIAGNOSTIC_TEST

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

urothelial carcinoma (UCC)

OncoPrism™ assay

Intervention Type DIAGNOSTIC_TEST

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

gastric or gastroesophageal junction adenocarcinoma

OncoPrism™ assay

Intervention Type DIAGNOSTIC_TEST

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

cervical cancer

OncoPrism™ assay

Intervention Type DIAGNOSTIC_TEST

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

esophageal squamous cell carcinoma (ESCC)

OncoPrism™ assay

Intervention Type DIAGNOSTIC_TEST

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

triple-negative breast cancer (TNBC)

OncoPrism™ assay

Intervention Type DIAGNOSTIC_TEST

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

hepatocellular carcinoma (HCC)

OncoPrism™ assay

Intervention Type DIAGNOSTIC_TEST

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

renal cell carcinoma (RCC)

OncoPrism™ assay

Intervention Type DIAGNOSTIC_TEST

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

colorectal cancer (CRC)

OncoPrism™ assay

Intervention Type DIAGNOSTIC_TEST

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Interventions

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OncoPrism™ assay

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Subject must have a disease of interest. Specifically, subject must have one of:

1. head and neck squamous cell carcinoma (HNSCC)
2. non-small-cell lung cancer (NSCLC)
3. small cell lung cancer (SCLC)
4. urothelial carcinoma (UCC)
5. gastric or gastroesophageal junction adenocarcinoma
6. cervical cancer
7. esophageal squamous cell carcinoma (ESCC)
8. triple-negative breast cancer (TNBC)
9. hepatocellular carcinoma (HCC)
10. renal cell carcinoma (RCC)
11. colorectal cancer (CRC)
2. Subject must have received, or be scheduled to receive, at least one dose of anti-PD-1/PD-L1 immunotherapy for treatment of their cancer.
3. Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
4. Subject must have undergone, or will undergo, medical imaging (e.g. CT or MRI) of the tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy.
5. Willing to provide electronic informed consent per IRB-approved protocol.
6. Able to speak, read, and comprehend English fluently.
7. Subject is 18 years of age or older.
8. Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.

Exclusion Criteria

1. Inability or unwillingness to provide informed consent.
2. Subject who does/did not have one of the cancers listed above (other histologies).
3. Subject has already participated in this trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Curebase Inc.

INDUSTRY

Sponsor Role collaborator

Cofactor Genomics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jarret Glasscock

Role: STUDY_DIRECTOR

Cofactor Genomics

Locations

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Curebase

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trial Coordinator

Role: CONTACT

(888) 602-0448

Facility Contacts

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Study Director

Role: primary

(628) 200-4082

References

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Flanagan KC, Earls J, Hiken J, Wellinghoff RL, Ponder MM, McLeod HL, Westra WH, Vavinskaya V, Sutton L, Deichaite I, Macdonald OK, Welaya K, Wade J 3rd, Azzi G, Pippas AW, Slim J, Bank B, Sui X, Kossman SE, Shenkenberg TD, Alexander WL, Price KA, Ley J, Messina DN, Glasscock JI, Colevas AD, Cohen EEW, Adkins D, Duncavage EJ. Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study. J Immunother Cancer. 2024 Nov 3;12(11):e009573. doi: 10.1136/jitc-2024-009573.

Reference Type DERIVED
PMID: 39489541 (View on PubMed)

Related Links

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Other Identifiers

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PREDAPT

Identifier Type: -

Identifier Source: org_study_id

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