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

Status
Closed
Cancer Type
Bladder Cancer
Breast Cancer
Colon/Rectal Cancer
Esophogeal Cancer
Kidney Cancer
Liver Cancer / Hepatoblastoma
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Solid Tumor
Stomach/ Gastric Cancer
Unknown Primary
Uterine Cancer
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Other
NCT ID
NCT03662204
Protocol IDs
2018-01 (primary)
NCI-2019-00765
Study Sponsor
Exact Sciences Corporation

Summary

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.

Objectives

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.

Eligibility

  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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.