Circulating Tumor DNA Exposure in Peripheral Blood

November 16, 2018 updated by: Quantgene Inc.

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

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).

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Recruiting
        • University Hospital of Geneva
        • Contact:
          • Pamela Sun, M.D.
        • Principal Investigator:
          • Frederic Ris, M.D.
        • Sub-Investigator:
          • Nicolas C Buchs, M.D.
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Active, not recruiting
        • University of Arizona Cancer Center
    • Florida
      • Celebration, Florida, United States, 34747
        • Recruiting
        • Florida Hospital Celebration Health
        • Contact:
          • Lorraine Hickson, MRA
        • Principal Investigator:
          • Olga Ivanov, MD
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health UF Health Cancer Center
        • Contact:
          • Vernique Walker
        • Principal Investigator:
          • Debashish Bose, MD, PhD
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Premier Surgical Oncology
        • Contact:
          • James Ouellette, D.O.
        • Principal Investigator:
          • James Ouellette, D.O
      • Dayton, Ohio, United States, 45429
        • Recruiting
        • Kettering Medical Center
        • Contact:
          • Molly Regan
        • Principal Investigator:
          • Minia Hellan, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Subjects that are diagnosed with a malignancy (cohort 1)
  • Subjects that have not been diagnosed with a malignancy (cohort 2)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1

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 1 must not:

• Have been treated for above diagnosed malignancy
Cohort 2

Negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2).

Subjects of cohort 2 must:

• Meet the listed matching criteria

Subjects of cohort 2 must not:

• Have been diagnosed/treated for a malignancy previously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study
Time Frame: 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).
28 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quantgene Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

May 7, 2018

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QG01012015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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