RECRUITING

ctDNA in Cutaneous Squamous Cell Carcinoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to test the potential for a liquid biopsy assay to detect residual disease after surgery in patients with cutaneous squamous cell carcinoma as well as the potential for this assay to monitor response to immunotherapy treatment.

Official Title

ctDNA Clearance and ctDNA Monitoring Study in Cutaneous Squamous Cell Carcinoma

Quick Facts

Study Start:2025-03-24
Study Completion:2029-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06875609

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with surgically resectable primary CSCC with PNI (\>0.1mm caliber nerve) or at least 2 high-risk features defined as size \> 2cm, recurrent CSCC, LVI, immunosuppressed, poorly differentiated, and/or invasion \>6mm/beyond subcutaneous fat;
  2. * Patients with surgically resectable regional metastases not receiving neoadjuvant therapy
  1. * Patients with Cutaneous Squamous Cell Carcinoma not amenable to surgical resection
  2. * Patients receiving or undergoing systemic therapies.

Contacts and Locations

Study Contact

Michael Cheung, MSc, CCRP
CONTACT
6175736060
mcheung0@meei.harvard.edu
Prerana Shivshanker, MPhil
CONTACT
6175736060
prerana_shivshanker@meei.harvard.edu

Principal Investigator

Sophia Z. Shalhout, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts Eye and Ear

Study Locations (Sites)

Massachusetts Eye and Ear
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts Eye and Ear Infirmary

  • Sophia Z. Shalhout, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Eye and Ear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-24
Study Completion Date2029-04-30

Study Record Updates

Study Start Date2025-03-24
Study Completion Date2029-04-30

Terms related to this study

Keywords Provided by Researchers

  • Circulating Tumor DNA
  • CSCC
  • Skin cancer
  • Biomarker
  • ctDNA
  • Minimal Residual Disease (MRD)
  • Liquid Biopsy
  • Advanced Skin Cancer

Additional Relevant MeSH Terms

  • Cutaneous Squamous Cell Carcinoma