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A Multicenter Cancer Biospecimen Collection Study

Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects tumor samples and health information with personal details removed. The samples may help researchers develop and check a future test for cancer. It is for adults with certain cancers who have had or will have a tumor biopsy before treatment and have received or will receive certain immune treatments.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have one of these cancers: squamous cell cancer of the head and neck or esophagus; small cell or non-small-cell lung cancer; urothelial cancer (in the urinary tract lining); adenocarcinoma of the stomach or where it joins the food pipe; cervical cancer; triple-negative breast cancer; hepatocellular cancer (in the liver); renal cell cancer (in the kidney); or colon or rectal cancer.
  • Have received or be scheduled to receive at least one dose of anti-PD-1/PD-L1 immunotherapy, a treatment that helps the immune system fight cancer.
  • Have had or will have a tumor biopsy (removal of a tissue sample) before starting that immune treatment.
  • Have had or will have scans of the tumor, such as CT or MRI, before starting that immune treatment.
  • Be willing to give electronic informed consent, meaning you understand the study and agree to join.
  • Be able to speak, read, and understand English well.
  • Be at least 18 years old.
  • Have enough tumor tissue available for the study.

Who can't join

  • Cannot or do not want to give informed consent.
  • Do not have one of the cancer types listed above.
  • Have already taken part in this study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

CA