Circulating Tumor DNA Exposure in Peripheral Blood

NCT03517332 | Unknown

• 1 other identifier: QG01012015
• Study Type: observational
• Target: 10,000
• Locations: 2 countries
• Sites: 6

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; Bladder Cancer; Melanoma; Ovarian Cancer; Adrenocortical Cancer; Breast Cancer; Other Cancer

Outcome Measures

Primary Outcomes (1)

• Circulating tumor DNA exposure in peripheral blood using a novel process: A 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).

  28 Months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• This study will include subjects that are diagnosed with a malignancy (cohort
• \) 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quantgene Inc.: lead

Study Sites (6)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

ACTIVE NOT RECRUITING

Florida Hospital Celebration Health

Celebration, Florida, 34747, United States

RECRUITING

Orlando Health UF Health Cancer Center

Orlando, Florida, 32806, United States

RECRUITING

Premier Surgical Oncology

Centerville, Ohio, 45459, United States

RECRUITING

Kettering Medical Center

Dayton, Ohio, 45429, United States

RECRUITING

University Hospital of Geneva

Geneva, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Circulating tumor DNA in blood samples

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Urinary Bladder Neoplasms; Melanoma; Ovarian Neoplasms; Adrenal Cortex Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Adrenal Gland Diseases; Breast Diseases

Central Study Contacts

Monika Hagen, M.D.

CONTACT

mh@quantgene.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 7, 2018
• Study Start: January 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

US (5); CH (1)