NCT05079113

Brief Summary

To generate meaningful data regarding ctDNA that would infer risk of recurrence in stage III melanoma patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

3.5 years

First QC Date

October 4, 2021

Last Update Submit

July 26, 2024

Conditions

Stage III MelanomaStage IV Cutaneous Melanoma

Outcome Measures

Primary Outcomes (1)

  • Identify a pattern for gene recognition of cancer recurrence earlier than standard of care.

    Genomic sequencing of 40+ ctDNA genes will be analyzed to identify genetic alterations correlating with the development of recurrence in melanoma.

    samples taken at baseline, 3 months, 6 months and 18 months.

Secondary Outcomes (1)

  • Analyze the genetic pathway associated with cancer recurrence and biologic information.

    samples taken at baseline, 3 months, 6 months and 18 months.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Retrospective biobanking samples collected at baseline, 3 months, 6 months and 18 months.

You may qualify if:

  • Age ≥18
  • Confirmed fully resected Stage IIIb-IV cutaneous melanoma; including patients treated neoadjuvantly within three months prior to resection.

You may not qualify if:

  • Treatment plan inconsistent with the standard of care systemic adjuvant therapies 4.0 Study Design

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer center

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Retrospectively collected blood samples from a biobank.

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • James Isaacs, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 15, 2021

Study Start

October 1, 2019

Primary Completion

April 4, 2023

Study Completion

April 4, 2023

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations

US(1)