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

Application of an Automated Liquid Biopsy System in the Detection of Colorectal Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03476122
Enrollment
750
Registered
2018-03-23
Start date
2018-03-15
Completion date
2021-03-13
Last updated
2018-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colo-rectal Cancer

Keywords

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

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.

Detailed description

1. Selection of patients: A. The disease group includes 300 patients diagnosed with stages 0-4 colorectal cancer not previously treated. B. The control group includes 450 control subjects who will undergo a colonoscopy procedure. 2. Study stages Stage I: The laboratory manually analyzes circulating tumor cells to establish a standard detection process for Automated Liquid Biopsy System Stage II: Comparison analysis between manual and Automated Liquid Biopsy Platform, establishing the procedural and analytical models for the Automated Liquid Biopsy Platform Stage III: Verification of the feasibility of use of an Automated Liquid Biopsy Platform in the clinical setting. 3. Methods I. CTC isolation Peripheral blood drawn from subjects will be processed using the CMx platform or the automated liquid biopsy system for detection and capture. II. Characterization of isolated CTC using Immunofluorescence Staining III. CRC-related gene expression The serum and circulating tumor cells isolated from the blood will be used to extract RNA, and then be analyzed with the expression of different genes by real-time quantitative polymerase chain reaction (real-time PCR).

Interventions

None listed

Sponsors

CellMaxLife
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 1\. The disease group is diagnosed with colorectal cancer 0-4 and has not been treated. * 2\. The control group will receive Colonoscopy * 3\. Above 20 years old

Exclusion criteria

* 1\. Refuse to sign the informed consent form * 2\. Received surgery within one month * 3\. Previous cancer history * 4\. Autoimmune diseases * 5\. Chronic inflammatory diseases * 6\. Acute inflammatory or infectious diseases in three months * 7\. Myelodysplastic syndromes and myeloproliferative disorder * 8\. Other diseases decided by PI

Design outcomes

Primary

MeasureTime frame
Detection of circulating tumor cellsPrior to treatment or colonoscopy

Countries

Taiwan

Contacts

Primary ContactYun-Tsui Chang
joy@cellmaxlife.com+886-2-26558455
Backup ContactWen-Jan Chiang
wenjan@cellmaxlife.com+886-2-26558455

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026