Clinical trial NCT03727087: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma
Official title: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Melanoma
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2018-11-01
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 350 subjects will be enrolled. Subjects will be men and women, 18 years of age and older, who have an untreated melanoma or a high suspicion of primary malignancy of melanoma.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood-based biomarkers associated with genetic and epigenetic alterations.
timeFrame: Point in time blood collection (1 day) at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc
state: California
city: Van Nuys
country: United States
facility: San Fernando Valley Health Institute
state: California
city: Middletown
country: United States
facility: Middlesex Hospital
state: Connecticut
city: Stamford
country: United States
facility: The Stamford Hospital
state: Connecticut
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Orange City
country: United States
facility: Mid-Florida Hematology and Oncology Center
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Buford
country: United States
facility: Balanced Life Health Care Solutions, LLC
state: Georgia
city: Columbus
country: United States
facility: IACT Health (DBA John B. Amos Cancer Center)
state: Georgia
city: Downers Grove
country: United States
facility: PMG Research, INC
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center NCI
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Health Indianapolis
state: Indiana
city: Edgewood
country: United States
facility: St. Elizabeth Medical Center
state: Kentucky
city: Rockville
country: United States
facility: DermAssociates, PC
state: Maryland
city: Grand Rapids
country: United States
facility: Cancer Research Consortium of West Michigan
state: Michigan
city: Bloomington
country: United States
facility: HealthPartner Institute
state: Minnesota
city: Petal
country: United States
facility: MediSync Clinical Research
state: Mississippi
city: Lincoln
country: United States
facility: Somnos Laboratories, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Cancer Alliance of Nebraska
state: Nebraska
city: Greenville
country: United States
facility: East Carolina University Brody School of Medicine
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Dayton
country: United States
facility: MediSync Clinical Research
state: Ohio
city: Spartanburg
country: United States
facility: Spartanburg Regional Healthcare District
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic Professional Association
state: Tennessee
city: Austin
country: United States
facility: MediSync Clinical Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Pflugerville
country: United States
facility: MediSync Clinical Research
state: Texas
city: Plano
country: United States
facility: Aim Trials, LLC
state: Texas
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital
state: Washington
city: Fort Atkinson
country: United States
facility: Dean Clinic - Fort Atkinson Specialty Services
state: Wisconsin
city: Green Bay
country: United States
facility: HSHS St Vincent Hospital Regional Cancer Center
state: Wisconsin
city: Oconomowoc
country: United States
facility: ProHealth Care
state: Wisconsin
Study officials:
References: