Adrenocortical Cancer, Bladder Cancer, Breast Cancer, Colorectal Cancer, Gastric Cancer, Hepatocellular Carcinoma, Melanoma, Non-small Cell Lung Cancer, Other Cancer, Ovarian Cancer, Pancreatic Adenocarcinoma
Conditions
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.
Interventions
None listed
Sponsors
Quantgene Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study | 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). |
Countries
Switzerland, United States
Contacts
Primary ContactMonika Hagen, M.D.
Outcome results
None listed