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A Multicenter Cancer Biospecimen Collection Study

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ClinicalTrials.gov Identifier: NCT04510129
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
Curebase, Inc.
Information provided by (Responsible Party):
Cofactor Genomics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
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 Diagnostic Test: OncoPrism™ assay

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 1650 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Group/Cohort Intervention/treatment
head and neck squamous cell carcinoma (HNSCC) Diagnostic Test: OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

non-small-cell lung cancer (NSCLC) Diagnostic Test: OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

small cell lung cancer (SCLC) Diagnostic Test: OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

urothelial carcinoma (UCC) Diagnostic Test: OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

gastric or gastroesophageal junction adenocarcinoma Diagnostic Test: OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

cervical cancer Diagnostic Test: OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

esophageal squamous cell carcinoma (ESCC) Diagnostic Test: OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

triple-negative breast cancer (TNBC) Diagnostic Test: OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

hepatocellular carcinoma (HCC) Diagnostic Test: OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

renal cell carcinoma (RCC) Diagnostic Test: OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

colorectal cancer (CRC) Diagnostic Test: OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.




Primary Outcome Measures :
  1. PD-L1/PD-1 inhibitor response [ Time Frame: 6 months ]
    No response to treatment with PD-L1/PD-1 inhibitor and response to treatment with PD-L1/PD-1 inhibitor.


Biospecimen Retention:   Samples Without DNA
Sections of subjects' pre-immunotherapy-treatment tumor biopsy, already collected as part of standard of care, will be collected as part of this study. Biopsy specimens may be used in subsequent studies for the development and validation of a diagnostic test.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510129


Contacts
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Contact: Adam Samson, MS 919-995-3511 adam@curebase.com
Contact: Hannah Gittleman 415-730-5547 hannah@curebase.com

Locations
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United States, California
Curebase Recruiting
San Francisco, California, United States, 94131
Contact: Adam Samson, MS    919-995-3511    adam@curebase.com   
Sponsors and Collaborators
Cofactor Genomics, Inc.
Curebase, Inc.
Additional Information:
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Responsible Party: Cofactor Genomics, Inc.
ClinicalTrials.gov Identifier: NCT04510129    
Other Study ID Numbers: PREDAPT
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Triple Negative Breast Neoplasms
Esophageal Squamous Cell Carcinoma
Head and Neck Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Carcinoma, Bronchogenic
Bronchial Neoplasms
Breast Neoplasms
Breast Diseases
Skin Diseases
Esophageal Neoplasms
Esophageal Diseases