Circulating Tumor Cells in mCRC for Liver Resection

NCT03295591 | Unknown

• 1 other identifier: UW17-008
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Resection of liver metastasis is potentially curative in patients with colorectal cancer bearing liver metastasis. However, early recurrence occurs in up to 30% in 3 months after liver resection. To optimize patient selection, the investigators propose to evaluate the the value of incorporating circulating tumor cells enumeration to clinical factors in a prospective study

Conditions

Metastatic Colorectal Cancer; Circulating Tumor Cell

Keywords

Metastatic colorectal cancer; Liver resection; Circulating tumor cells

Outcome Measures

Primary Outcomes (1)

• Cutoff value of CTC counts

  to identify patients with early relapse (\<6 months) after liver resection as determined by the AUC under the ROC curve

  Progression free survival at 6 months

Secondary Outcomes (3)

• A immuno-clinical scoring system

  Progression free survival at 6 months

• Progression free survival

  up to 5 years

• Overall survival

  up to 5 years

Interventions

Circulating tumor cell DIAGNOSTIC_TEST

Circulating tumor cell enumeration and sequencing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with colorectal cancer and liver metastasis who are planned for liver resection

You may qualify if:

• Age\>=18 years
• Signed informed consent
• Histologically or cytologically confirmed colorectal adenocarcinoma
• Both primary tumor and liver metastases are amenable to curative resection.

You may not qualify if:

• Presence of extrahepatic metastasis
• History of other malignancies in the last 5 years
• Patients unable to comply with the protocol

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood in Streck tube will be processed for isolating circulating tumor cells and its DNA content for subsequent sequencing if feasible

MeSH Terms

Conditions

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

• Ka On Lam, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka On Lam, MBBS

CONTACT

22554352; lamkaon@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 28, 2017
• Study Start: June 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: March 31, 2020
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

HK (1)