Circulating Tumor DNA Exposure in Peripheral Blood

Breast Cancer Clinical Trial

Official title:

Circulating Tumor DNA Exposure in Peripheral Blood Using a Novel Process: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03517332
• Other study ID #: QG01012015
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2018
• Source: Quantgene Inc.
• Contact: Monika Hagen, M.D.
• Email: mh[@]quantgene.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adrenal Cortex Neoplasms
• Adrenocortical Cancer
• Adrenocortical Carcinoma
• Bladder Cancer
• Breast Cancer
• Carcinoma, Hepatocellular
• Carcinoma, Non-Small-Cell Lung
• Colorectal Cancer
• Colorectal Neoplasms
• Gastric Cancer
• Hepatocellular Carcinoma
• Melanoma
• Non-small Cell Lung Cancer
• Other Cancer
• Ovarian Cancer
• Pancreatic Adenocarcinoma
• Stomach Neoplasms
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva	Geneva
United States	Florida Hospital Celebration Health	Celebration	Florida
United States	Premier Surgical Oncology	Centerville	Ohio
United States	Kettering Medical Center	Dayton	Ohio
United States	Orlando Health UF Health Cancer Center	Orlando	Florida
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Quantgene Inc.

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating tumor DNA exposure in peripheral blood using a novel process: A 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).	28 Months