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

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

  • Org Study ID: QG01012015
  • Secondary ID:
  • NCT ID: NCT03517332
  • NCT Alias:
  • Sponsor: Quantgene Inc. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting January 1, 2015 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study

Primary Outcome 1 - Time Frame: 28 Months


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


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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Name: Monika Hagen, M.D.




Facility Status Contact
University of Arizona Cancer Center
Tucson, Arizona 85724
United States
Active, not recruiting
Florida Hospital Celebration Health
Celebration, Florida 34747
United States
Recruiting Lorraine Hickson, MRA

Orlando Health UF Health Cancer Center
Orlando, Florida 32806
United States
Recruiting Vernique Walker

Premier Surgical Oncology
Centerville, Ohio 45459
United States
Recruiting James Ouellette, D.O.

Kettering Medical Center
Dayton, Ohio 45429
United States
Recruiting Molly Regan

University Hospital of Geneva
Recruiting Pamela Sun, M.D.