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Circulating Tumor DNA Exposure in Peripheral Blood

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ClinicalTrials.gov Identifier: NCT03517332
Recruitment Status : Recruiting
First Posted : May 7, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
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).

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

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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Tumor DNA Exposure in Peripheral Blood Using a Novel Process: A Feasibility Study
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


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




Primary Outcome Measures :
  1. 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).


Biospecimen Retention:   Samples With DNA
Circulating tumor DNA in blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517332


Contacts
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Contact: Monika Hagen, M.D. mh@quantgene.com

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

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Responsible Party: Quantgene Inc.
ClinicalTrials.gov Identifier: NCT03517332     History of Changes
Other Study ID Numbers: QG01012015
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Urinary Bladder Neoplasms
Adrenal Cortex Neoplasms
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Urogenital Neoplasms
Liver Neoplasms
Urologic Neoplasms
Adrenal Gland Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Carcinoma, Hepatocellular
Adrenocortical Carcinoma
Carcinoma, Bronchogenic
Lung Diseases
Respiratory Tract Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases