single blood draw for early detect of cancer early detection of cancer - blood test
Conditions
Interventions
None listed
Sponsors
Exact Sciences Thrive LLC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All subjects 1. >=50 years of age 2. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. Cancer Subjects Only 3. Subject has an untreated primary malignancy of 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 confirmed through pathology reports and/or clinical/radiographic data. Or 4. Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.
Exclusion criteria
Exclusion criteria: 1. Prior or concurrent cancer diagnosis defined as: a. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR b. Recurrence of the same primary cancer within any timeframe; OR c. Concurrent diagnosis of multiple primary cancers 2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection. 3. Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection. 4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection. 5. Less than 7 days between biopsy (other than FNA) of target pathology and blood collection. 6. IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] prior to blood collection. 7. Individual has a condition the Investigator believes would interfere with the subject*s ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. 8. Participant has an active febrile infection prior to blood draw 9. History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The purpose of this study is to obtain clinically characterized, whole blood specimens from cancer subjects and healthy subjects to develop and refine assays for cancer in the blood. | — |
Countries
Netherlands
Outcome results
None listed