IRB Study Number 22-266
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Respiratory Institute
Description
The purpose of study is to evaluate a blood test (also called a liquid biopsy) designed to detect multiple types of cancer at the earliest stages possible. Participants will be asked to give up to four (4) tablespoons (or about 50mL) of blood. The blood draw can happen the same day the participant is enrolled in the study or any time prior to beginning treatment, if applicable.
Inclusion Criteria
50 years or older
Participant has untreated cancer with one of the following primary malignancies: breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian, esophageal cancer, head and neck squamous cell, thyroid, small intestine, cervical, anal, vulva, or testis
OR
- Participant has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.
Exclusion Criteria
- Participant has another cancer that:
a. Was diagnosed within the last 5 years (basal cell or squamous cell skin cancers are permitted)
OR
b. Is a recurrence of any cancer participant has had in the past
OR
c. Is a diagnosis that involves multiple primary cancers
Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
Any treatment for the primary malignancy or sites of metastases.
Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection.
Participant has an active febrile infection prior to blood draw.
History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.
