Circulating Tumor DNA Exposure in Peripheral Blood

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2019-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes