Clinical trial NCT03517332: Circulating Tumor DNA Exposure in Peripheral Blood
Official title: Circulating Tumor DNA Exposure in Peripheral Blood Using a Novel Process: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Pancreatic Adenocarcinoma
Gastric Cancer
Hepatocellular Carcinoma
Non-small Cell Lung Cancer
Bladder Cancer
Melanoma
Ovarian Cancer
Adrenocortical Cancer
Breast Cancer
Other Cancer
Lead sponsor: Quantgene Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-07
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility 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

Primary outcomes:
measure: Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study
timeFrame: 28 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Celebration
country: United States
facility: Florida Hospital Celebration Health
state: Florida
city: Orlando
country: United States
facility: Orlando Health UF Health Cancer Center
state: Florida
city: Centerville
country: United States
facility: Premier Surgical Oncology
state: Ohio
city: Dayton
country: United States
facility: Kettering Medical Center
state: Ohio
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
Study officials:
References: