A Study to Assess a Multicenter Cancer Biospecimen Collection
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-012917
Sponsor Protocol Number: PREDAPT-2
About this study
This is a retrospective specimen acquisition study of pre-treatment head and neck squamous cell carcinoma tumor biopsy samples. The sponsor-provided protocol allows for multiple different tumor types. However, Mayo Clinic, Rochester will only enroll head and neck squamous cell carcinoma.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subject must have a disease of interest. Specifically, subject must have one of:
- head and neck squamous cell carcinoma (HNSCC);
- non-small-cell lung cancer (NSCLC);
- small cell lung cancer (SCLC);
- urothelial carcinoma (UCC);
- gastric or gastroesophageal junction adenocarcinoma;
- cervical cancer;
- esophageal squamous cell carcinoma (ESCC);
- triple-negative breast cancer (TNBC);
- hepatocellular carcinoma (HCC);
- renal cell carcinoma (RCC);
- colorectal cancer (CRC).
- 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.
- Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
- 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.
- Willing to provide electronic informed consent per IRB-approved protocol.
- Able to speak, read, and comprehend English fluently.
- Subject is 18 years of age or older.
- Subjects must have sufficient tissue available to fulfill the specimen requirements of the study, as defined in the SPECIMENS TO BE COLLECTED section of this protocol.
Exclusion Criteria:
- Inability or unwillingness to provide informed consent.
- Subject who does/did not have one of the cancers listed above (other histologies).
- Subject has already participated in this trial.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Katharine Price, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available