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

Purpose

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.

Conditions

  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Bladder Cancer
  • Uterine Cancer
  • Kidney Cancer
  • Renal Pelvis Cancer
  • Pancreatic Cancer
  • Liver Cancer
  • Stomach Cancer
  • Ovarian Cancer
  • Esophageal Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
Breast 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.
Lung 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.
Colorectal 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.
Prostate 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.
Bladder 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.
Uterine 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.
Kidney & Renal Pelvis 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.
Pancreatic 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.
Liver 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.
Stomach 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.
Ovarian 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.
Esophageal 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.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.

More Details

Status
Completed
Sponsor
Exact Sciences Corporation

Study Contact

Detailed 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.