Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma

Terminated

• Conditions: Melanoma

• Registration Number: NCT03727087
• Lead Sponsor: Exact Sciences Corporation

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.

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-11-01
• Study Start: 2019-01-10
• Primary Completion: 2020-03-24
• Study Completion: 2020-03-24
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

1. Subject is male or female > 18 years of age.

2. Subject has an untreated primary melanoma.

   OR

   Subject has high suspicion of primary malignancy of melanoma based on skin exam or 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 5 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood-based biomarkers associated with genetic and epigenetic alterations.	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.

Trial Locations

Locations (33)

CARTI Cancer Center; 🇺🇸 Little Rock, Arkansas, United States

Alliance Research Centers; 🇺🇸 Laguna Hills, California, United States

Palmtree Clinical Research, Inc; 🇺🇸 Palm Springs, California, United States

San Fernando Valley Health Institute; 🇺🇸 Van Nuys, California, United States

Middlesex Hospital; 🇺🇸 Middletown, Connecticut, United States

The Stamford Hospital; 🇺🇸 Stamford, Connecticut, United States

Direct Helpers Research Center; 🇺🇸 Hialeah, Florida, United States

East Coast Institute for Research, LLC; 🇺🇸 Jacksonville, Florida, United States

Mid-Florida Hematology and Oncology Center; 🇺🇸 Orange City, Florida, United States

Olympian Clinical Research; 🇺🇸 Tampa, Florida, United States

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