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

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04354064
• Collaborator: Roche Sequencing Solutions (Industry), The Foundation for Barnes-Jewish Hospital (Other), National Center for Advancing Translational Science (NCATS) (NIH), Radiological Society of North America (Other), Skandalaris (Other), The V Foundation for Cancer Research (Other), National Institute of General Medical Sciences (NIGMS) (NIH)
• Enrollment: 3,362
• Location: 1
• Anticipated Duration (Months): 79.1
• Patients Per Site Per Month: 42.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 3362 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
• Actual Study Start Date: May 29, 2019
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Healthy Donor Samples Donation of blood and/or urine samples as often as bi-monthly and as many as 24 times in total 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 Repository Tissue, blood, and/or drain fluid samples from Head and Neck Banking studies Tissue and/or blood samples from Esophageal Repository Tissue and/or blood samples from Genitourinary Repository Tissue and/or plasma from Sarcoma Tissue Bank Tissue and/or plasma from Breast Cancer Bank Tissue, plasma, and/or urine from GI Tissue and Blood Bank Tissue, blood, and/or urine from Solid Tumor Bank Tissue, blood, and/or urine from Lung Cancer Bank Tissue and/or blood from Skin Cancer Bank

Outcome Measures

Primary Outcome Measures

1. Freedom from progression [Through completion of study (estimated to be 6.5 years)]

   -Defined as RECIST 1.1 based radiographic or clinical progression, with non-progressors censored at last radiographic follow-up

Secondary Outcome Measures

1. Event-free survival [Through completion of study (estimated to be 6.5 years)]

   -Defined as post-treatment ctDNA detection or RECIST 1.1 based radiographic progression

2. Disease-specific survival [Through completion of study (estimated to be 6.5 years)]

   -Defined as death from cancer

3. Overall survival [Through completion of study (estimated to be 6.5 years)]

   -Defined as death from any cause

4. Pathologic complete response rate [Through completion of study (estimated to be 6.5 years)]

5. Locoregional failure [Through completion of study (estimated to be 6.5 years)]

   -Defined as clinical or radiographic progression within the localized tumor/treatment area or regional lymph nodes

6. Distant-metastasis-free survival [Through completion of study (estimated to be 6.5 years)]

   -Defined as clinical or radiographic progression outside the localized tumor/treatment area and regional lymph nodes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Healthy donors younger than 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine
• Roche Sequencing Solutions
• The Foundation for Barnes-Jewish Hospital
• National Center for Advancing Translational Science (NCATS)
• Radiological Society of North America
• Skandalaris
• The V Foundation for Cancer Research
• National Institute of General Medical Sciences (NIGMS)

Investigators

• Principal Investigator: Aadel Chaudhuri, M.D., Ph.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04354064
• Other Study ID Numbers: 201903142
• First Posted: Apr 21, 2020
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastrointestinal Neoplasms; Urogenital Neoplasms

Study Results

No Results Posted as of Apr 12, 2022