Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors

Clinicaltrials.gov ID: NCT04354064
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 100

Conditions

Healthy Volunteer, Prostate Cancer, Head and Neck Cancer, Esophageal Cancer, Genitourinary Cancer, Sarcoma, Breast Cancer, Colon Cancer, Gastrointestinal Cancer, Solid Tumor Cancer, Lung Cancer, Skin Cancer, Melanoma

Summary

Earlier detection of disease recurrence will enable greater treatment options and has strong potential to improve patient outcomes. This project is translational and has the potential to lead to future translational research opportunities, including interventional trials in which therapeutic escalation is offered at the early circulating tumor DNA (ctDNA) molecular residual disease (MRD) detection timepoint. Ultimately, the integration of ctDNA into the clinical workflow has the potential to enhance cancer diagnosis, treatment, surveillance, and prognosis, and guide clinical decision-making in this era of personalized precision medicine.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Russell Pachynski, M.D.

Eligibility Criteria

Inclusion Criteria:

* Eligible healthy donors will be at least 18 years of age.

Exclusion Criteria:

* Healthy donors younger than 18 years of age

Study Plan

Healthy Donor Samples

* Donation of blood and/or urine samples as often as bi-monthly and as many as 24 times in totaln* These samples will be used to generate reference data to compare patient data to and/or to correct stereotypic noise.

Samples from Repository and Banking Studies

* Healthy prostate and/or blood and/or urine samples from Genitourinary Repositoryn* Tissue, blood, and/or drain fluid samples from Head and Neck Banking studiesn* Tissue and/or blood samples from Esophageal Repositoryn* Tissue and/or blood samples from Genitourinary Repositoryn* Tissue and/or plasma from Sarcoma Tissue Bankn* Tissue and/or plasma from Breast Cancer Bankn* Tissue, plasma, and/or urine from GI Tissue and Blood Bankn* Tissue, blood, and/or urine from Solid Tumor Bankn* Tissue, blood, and/or urine from Lung Cancer Bankn* Tissue and/or blood from Skin Cancer Bankn* Tissue and/or blood from Pediatric Neurosurgery Tissue Bank

Outcome Measures

Primary Outcome Measures

Freedom from progression

Time Frame: Through completion of study (estimated to be 6.5 years)

Secondary Outcome Measures

Event-free survival

Time Frame: Through completion of study (estimated to be 6.5 years)

Disease-specific survival

Time Frame: Through completion of study (estimated to be 6.5 years)

Overall survival

Time Frame: Through completion of study (estimated to be 6.5 years)

Pathologic complete response rate

Time Frame: Through completion of study (estimated to be 6.5 years)

Locoregional failure

Time Frame: Through completion of study (estimated to be 6.5 years)

Distant-metastasis-free survival

Time Frame: Through completion of study (estimated to be 6.5 years)

Timeline

  • Last Updated
    January 3, 2024
  • Start Date
    April 21, 2020
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    December 31, 2025

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