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

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 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. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin 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 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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Katherine Hesler
617-726-2153
khesler@mgh.harvard.edu

More Details

NCT ID
NCT03662204
Status
Recruiting
Sponsor
Exact Sciences Corporation

Study Contact

Alexandra Massoud
608-957-5652
amassoud@exactsciences.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.