Recruiting

Observational Study

Sponsor:

Quantgene Inc.

Code:

NCT03517332

Conditions

Colorectal Cancer

Pancreatic Adenocarcinoma

Gastric Cancer

Hepatocellular Carcinoma

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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).

Conditions

Colorectal Cancer

Pancreatic Adenocarcinoma

Gastric Cancer

Hepatocellular Carcinoma

Non-small Cell Lung Cancer

Study ID

NCT03517332

Start date

Jan 1, 2015

Status verified date

Nov, 2018

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study [ Time Frame: 28 Months ]

Central Contacts and Locations

Central contacts

Monika Hagen, M.D.

mh@quantgene.com

Locations

Florida Hospital Celebration Health

Recruiting

Celebration, Florida, United States, 34747

Principal Investigator:

Olga Ivanov, MD

Orlando Health UF Health Cancer Center

Recruiting

Orlando, Florida, United States, 32806

Principal Investigator:

Debashish Bose, MD, PhD

Premier Surgical Oncology

Recruiting

Centerville, Ohio, United States, 45459

Principal Investigator:

James Ouellette, D.O

Kettering Medical Center

Recruiting

Dayton, Ohio, United States, 45429

Principal Investigator:

Minia Hellan, M.D.

More Information

Sponsor

Quantgene Inc.

Last update posted

Nov 20, 2018

Last verified

Nov, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Quantgene Inc. on 2018-11-20.