Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma

Melanoma Clinical Trial

Official title:

Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03727087
• Other study ID #: 2018-03
• Status: Terminated
• Start date: January 10, 2019
• Est. completion date: March 24, 2020

Study information

• Verified date: February 2021
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 348
• Est. completion date: March 24, 2020
• Est. primary completion date: March 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Locations

Country	Name	City	State
United States	MediSync Clinical Research	Austin	Texas
United States	HealthPartner Institute	Bloomington	Minnesota
United States	Balanced Life Health Care Solutions, LLC	Buford	Georgia
United States	IACT Health (DBA John B. Amos Cancer Center)	Columbus	Georgia
United States	MediSync Clinical Research	Dayton	Ohio
United States	PMG Research, INC	Downers Grove	Illinois
United States	St. Elizabeth Medical Center	Edgewood	Kentucky
United States	Dean Clinic - Fort Atkinson Specialty Services	Fort Atkinson	Wisconsin
United States	Cancer Research Consortium of West Michigan	Grand Rapids	Michigan
United States	HSHS St Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	East Carolina University Brody School of Medicine	Greenville	North Carolina
United States	Direct Helpers Research Center	Hialeah	Florida
United States	Franciscan Health Indianapolis	Indianapolis	Indiana
United States	The Jackson Clinic Professional Association	Jackson	Tennessee
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	Alliance Research Centers	Laguna Hills	California
United States	Somnos Laboratories, Inc.	Lincoln	Nebraska
United States	CARTI Cancer Center	Little Rock	Arkansas
United States	Middlesex Hospital	Middletown	Connecticut
United States	ProHealth Care	Oconomowoc	Wisconsin
United States	Cancer Alliance of Nebraska	Omaha	Nebraska
United States	Mid-Florida Hematology and Oncology Center	Orange City	Florida
United States	Palmtree Clinical Research, Inc	Palm Springs	California
United States	MediSync Clinical Research	Petal	Mississippi
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	MediSync Clinical Research	Pflugerville	Texas
United States	Aim Trials, LLC	Plano	Texas
United States	DermAssociates, PC	Rockville	Maryland
United States	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina
United States	Spartanburg Regional Healthcare District	Spartanburg	South Carolina
United States	The Stamford Hospital	Stamford	Connecticut
United States	Olympian Clinical Research	Tampa	Florida
United States	Carle Cancer Center NCI	Urbana	Illinois
United States	San Fernando Valley Health Institute	Van Nuys	California
United States	Wenatchee Valley Hospital	Wenatchee	Washington
United States	Lexington Medical Center	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood-based biomarkers associated with genetic and epigenetic alterations.	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.	Point in time blood collection (1 day) at enrollment