Circulating Tumor DNA Exposure in Peripheral Blood

• Conditions: Hepatocellular Carcinoma; Ovarian Cancer; Breast Cancer; Pancreatic Adenocarcinoma; Melanoma; Adrenocortical Cancer; Gastric Cancer; Other Cancer; Colorectal Cancer; Non-small Cell Lung Cancer

• Registration Number: NCT03517332
• Lead Sponsor: Quantgene Inc.

Brief Summary

This is a prospective, multi-center, blinded feasibility study. The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).

Detailed Description

This prospective, multi-center, feasibility study represents a feasibility study to determine the potential of circulating tumor DNA exposure in peripheral blood using a novel process in a sample of patients with different types of malignant organ tumors and a control cohort without malignant disease. The study applies a new process to detect ctDNA and other molecular markers in peripheral blood using: a collection of de-identified blood specimen and clinical data from up to 10,000 participants from clinical sites across the United States and Europe. Data collected will include the following: Demographics, Tumor Characteristics, Information about Treatment, Specimen Assessment, Postoperative Assessment Clinical information, and Follow-up at intermittent future time points, for up to 15 years. The study test(s) to be used in this protocol is a multiplexed primer and probe design developed, that allows detecting a wider set of mutations at a higher sensitivity then conventional sequencing-based method. This novel process is currently being investigated at Quantgene Inc.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-05-07
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-20
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• This study will include subjects that are diagnosed with a malignancy (cohort

  1. and a negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2).

• Subjects of both cohorts must:

  • Be of age ≥ 18
  • Provide written consent for study participation

• Subject of cohort 1 must:

  • Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma

Subjects of cohort 2 must:

• Meet the listed matching criteria

Exclusion Criteria

• Subjects of cohort 1 must not: Have been treated for above diagnosed malignancy

• Subjects of cohort 2 must not:

  • Have been diagnosed/treated for a malignancy previously

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study	28 Months	The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).

Trial Locations

Locations (6)

University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Orlando Health UF Health Cancer Center; 🇺🇸 Orlando, Florida, United States

Premier Surgical Oncology; 🇺🇸 Centerville, Ohio, United States

University Hospital of Geneva; 🇨🇭 Geneva, Switzerland

Florida Hospital Celebration Health; 🇺🇸 Celebration, Florida, United States

Kettering Medical Center; 🇺🇸 Dayton, Ohio, United States