Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Exact Sciences Corporation

Status: Completed

Conditions: Breast Cancer; Uterine Cancer; Esophageal Cancer; Lung Cancer; Ovarian Cancer; Liver Cancer; Bladder Cancer; Kidney Cancer; Renal Pelvis Cancer; Stomach Cancer; Prostate Cancer; Pancreatic Cancer; Colorectal Cancer

Treatments: Other: Blood Sample Collection

Study type: Observational

Funder types: Industry

Identifiers

NCT03662204

2018-01

Details and patient eligibility

About

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Full description

Subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with any solid tumor. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.

Enrollment: 5,133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is male or female > 18 years of age.

2. Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.

   OR

   Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, or ovarian cancer based on imaging.

3. 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.

Exclusion criteria

1. Prior or concurrent cancer diagnosis defined as:

   1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
   2. Recurrence of the same primary cancer within any timeframe; OR
   3. 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] of blood collection.

7. Individual has a condition the Investigator believes would interfere with his or her 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.

Trial design

5,133 participants in 12 patient groups

Breast

Description:

Subjects with clinically confirmed breast cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection

Lung

Description:

Subjects with clinically confirmed lung cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection

Colorectal

Description:

Subjects with clinically confirmed colorectal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection

Prostate

Description:

Subjects with clinically confirmed prostate cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection

Bladder

Description:

Subjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection

Uterine

Description:

Subjects with clinically confirmed uterine cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection

Kidney & Renal Pelvis

Description:

Subjects with clinically confirmed or suspicion of kidney or renal pelvis cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection

Pancreatic

Description:

Subjects with clinically confirmed or suspicion of pancreatic cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection

Liver

Description:

Subjects with clinically confirmed liver cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection

Stomach

Description:

Subjects with clinically confirmed stomach cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection

Ovarian

Description:

Subjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection

Esophageal

Description:

Subjects with clinically confirmed esophageal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Treatment:

Other: Blood Sample Collection