Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma

Exact Sciences Corporation33 sites in 1 country348 target enrollmentJanuary 10, 2019

ConditionsMelanoma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Melanoma
Sponsor: Exact Sciences Corporation
Enrollment: 348
Locations: 33
Primary Endpoint: Blood-based biomarkers associated with genetic and epigenetic alterations.
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Subjects will have been recently diagnosed with untreated melanoma. 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.

Registry

clinicaltrials.gov

Start Date

January 10, 2019

End Date

March 24, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Exact Sciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is male or female \> 18 years of age.
•Subject has an untreated primary melanoma.
•Subject has high suspicion of primary malignancy of melanoma based on skin exam or imaging.
•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

•Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
•Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
•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.
•Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
•Less than 5 days between biopsy (other than FNA) of target pathology and blood collection.
•IV contrast (e.g. CT and MRI) within 1 day \[or 24 hours\] of blood collection.
•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.

Outcomes

Primary Outcomes

Blood-based biomarkers associated with genetic and epigenetic alterations.

Time Frame: Point in time blood collection (1 day) at enrollment

Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with melanoma at the pre-intervention stage.