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Solid Tumors, Blood Sample Collection to Evaluate Biomarkers (2018-01)

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

Objective

Overview

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.

Key Inclusion Criteria

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.

Key Inclusion Criteria

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.

Phase: Observational

                          Learn More

                          IRB Protocol Number
                          2018-01
                          Principal Investigator(s)
                          Abderrahim Kohmani, M.D.

                          Clinical Trial Categories

                          • Thoracic Cancer
                          • Breast Cancer
                          • Gastrointestinal Cancer
                          • Genitourinary Cancer
                          • Gynecologic Cancer
                          Sponsor(s)
                          Exact Sciences Corporation
                          Contact
                          Tom Leuck, RN at 864-560-1980
                          or tleuck@gibbscc.org
                          How to Participate

                          Tom Leuck

                          864-560-6812

                          tleuck@srhs.com

                          Location

                          • Gibbs Cancer Center & Research Institute – Spartanburg
                            380 Serpentine Drive
                            Spartanburg, SC 29303

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