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Trial record 1 of 5 for:    Blood Sample Collection to Evaluate Biomarkers in Subjects with Untreated
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Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727087
Recruitment Status : Terminated (COVID-19)
First Posted : November 1, 2018
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Melanoma Other: Blood Sample Collection

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.

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Study Type : Observational
Actual Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma
Actual Study Start Date : January 10, 2019
Actual Primary Completion Date : March 24, 2020
Actual Study Completion Date : March 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Group/Cohort Intervention/treatment
Melanoma
Subjects with clinically confirmed melanoma or high suspicion of a primary malignancy of melanoma based on skin exam or imaging and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727087


Locations
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Sponsors and Collaborators
Exact Sciences Corporation
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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT03727087    
Other Study ID Numbers: 2018-03
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
Access Criteria: Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas