Clinical Application of an Automated Liquid Biopsy Platform for Early Detection of Colorectal Cancer

NCT03476122 | Unknown

• 1 other identifier: CMx-CTC-CRC-001
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is among the most preventable cancers when precancerous lesions are detected at an early stage. Current screening methods for CRC require bowel prep or stool-based testing that are inconvenient, resulting in low compliance. Stool based tests have limited sensitivity for the detection of precancerous lesions. The CMx platform has been showed to be able to the detection of Circulating Tumor Cells (CTCs) in high sensitivity and specificity. In published studies, circulating Tumor Cells (CTCs) are captured and quantified in advanced-stages of colorectal cancer. In order to detect early and pre-cancer circulating tumor cells, we have developed an Automated Liquid Biopsy Platform that improves the detection of CTCs in early cancer stages. Therefore, this study goals are: 1) to establish a standard detection process utilizing the Automated Liquid Biopsy Platform. 2) Parallel comparison of laboratory manual operation and Automated Liquid Biopsy Platform. 3) Verify the feasibility of use of an Automated Liquid Biopsy Platform in the clinical setting.

Conditions

Colo-rectal Cancer

Keywords

Colorectal cancer; CRC; Circulating tumor cells; CTCs; Early detection; Automated

Outcome Measures

Primary Outcomes (1)

• Detection of circulating tumor cells

  Prior to treatment or colonoscopy

Study Arms (2)

Disease Group

The disease group is diagnosed with colorectal cancer 0-4 and has not been treated.

Control Group

The control group will receive Colonoscopy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Colorectal cancer patients

You may qualify if:

• \. The disease group is diagnosed with colorectal cancer 0-4 and has not been treated.
• \. The control group will receive Colonoscopy
• \. Above 20 years old

You may not qualify if:

• \. Refuse to sign the informed consent form
• \. Received surgery within one month
• \. Previous cancer history
• \. Autoimmune diseases
• \. Chronic inflammatory diseases
• \. Acute inflammatory or infectious diseases in three months
• \. Myelodysplastic syndromes and myeloproliferative disorder
• \. Other diseases decided by PI

Sponsors & Collaborators

• CellMaxLife: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms; Neoplastic Cells, Circulating

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; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wen-Sy Tsai

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-Tsui Chang

CONTACT

+886-2-26558455; joy@cellmaxlife.com

Wen-Jan Chiang

CONTACT

+886-2-26558455; wenjan@cellmaxlife.com

Study Design

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

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 23, 2018
• Study Start: March 15, 2018
• Primary Completion: January 1, 2019
• Study Completion: March 13, 2021
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

TW (1)