MelanomaNCT03727087
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma
An observational study of Melanoma, run by Exact Sciences Corporation at 36 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Blood Sample Collection
- How many people
- 348 participants
- Where
- 36 sitesUnited States
- Study dates
- 10 Jan 2019to 24 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subject is male or female > 18 years of age.
- Subject has an untreated primary melanoma.
- OR
- 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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
MediSync Clinical Research
Austin, Texas, 78726
HealthPartner Institute
Bloomington, Minnesota, 55425
Balanced Life Health Care Solutions, LLC
Buford, Georgia, 30518
IACT Health (DBA John B. Amos Cancer Center)
Columbus, Georgia, 31904
MediSync Clinical Research
Dayton, Ohio, 45419
PMG Research, INC
Downers Grove, Illinois, 60515
St. Elizabeth Medical Center
Edgewood, Kentucky, 41017
Dean Clinic - Fort Atkinson Specialty Services
Fort Atkinson, Wisconsin, 53538
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, 49503
HSHS St Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301
East Carolina University Brody School of Medicine
Greenville, North Carolina, 27834
Direct Helpers Research Center
Hialeah, Florida, 33012
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
The Jackson Clinic Professional Association
Jackson, Tennessee, 38305
East Coast Institute for Research, LLC
Jacksonville, Florida, 32204
Alliance Research Centers
Laguna Hills, California, 92653
Somnos Laboratories, Inc.
Lincoln, Nebraska, 68510
CARTI Cancer Center
Little Rock, Arkansas, 72205
Middlesex Hospital
Middletown, Connecticut, 06457
ProHealth Care
Oconomowoc, Wisconsin, 53066
Cancer Alliance of Nebraska
Omaha, Nebraska, 68106
Mid-Florida Hematology and Oncology Center
Orange City, Florida, 32765
Palmtree Clinical Research, Inc
Palm Springs, California, 92262
MediSync Clinical Research
Petal, Mississippi, 39465
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
MediSync Clinical Research
Pflugerville, Texas, 78660
Aim Trials, LLC
Plano, Texas, 75093
DermAssociates, PC
Rockville, Maryland, 20850
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804
Spartanburg Regional Healthcare District
Spartanburg, South Carolina, 29301
The Stamford Hospital
Stamford, Connecticut, 06904
Olympian Clinical Research
Tampa, Florida, 33609
Carle Cancer Center NCI
Urbana, Illinois, 61801
San Fernando Valley Health Institute
Van Nuys, California, 91405
Wenatchee Valley Hospital
Wenatchee, Washington, 98801
Lexington Medical Center
West Columbia, South Carolina, 29169
About this study
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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- Blood Sample Collection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
Subjects participating in the study will have blood drawn at enrollment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Point in time blood collection (1 day) at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start10 Jan 2019
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727087
- Sponsor's protocol ID
- 2018-03
- Status last verified
- Feb 2021
- First submitted
- 23 Oct 2018
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma
- ClinicalTrials.gov ID
- NCT03727087
- Acronym / sponsor ID
- 2018-03
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanoma | – | Other: Blood Sample CollectionSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Subject is male or female > 18 years of age.
- Subject has an untreated primary melanoma.
- OR
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionSubjects participating in the study will have blood drawn at enrollment. | Other | Melanoma |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Exact Sciences Corporation at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood-based biomarkers associated with genetic and epigenetic alterations. (time frame: Point in time blood collection (1 day) at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.