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

Study Overview
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Brief Summary
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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.

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

Conditions
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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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible healthy donors will be at least 18 years of age. Exclusion Criteria: Healthy donors younger than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Donor Samples<br>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<br>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 Tissue and/or blood from Pediatric Neurosurgery Tissue Bank | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from progression | -Defined as RECIST 1.1 based radiographic or clinical progression, with non-progressors censored at last radiographic follow-up | Through completion of study (estimated to be 6.5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival | -Defined as post-treatment ctDNA detection or RECIST 1.1 based radiographic progression | Through completion of study (estimated to be 6.5 years) | 
| Disease-specific survival | -Defined as death from cancer | Through completion of study (estimated to be 6.5 years) | 
| Overall survival | -Defined as death from any cause | Through completion of study (estimated to be 6.5 years) | 
| Pathologic complete response rate |  | Through completion of study (estimated to be 6.5 years) | 
| Locoregional failure | -Defined as clinical or radiographic progression within the localized tumor/treatment area or regional lymph nodes | Through completion of study (estimated to be 6.5 years) | 
| Distant-metastasis-free survival | -Defined as clinical or radiographic progression outside the localized tumor/treatment area and regional lymph nodes | Through completion of study (estimated to be 6.5 years) |