Surgical Treatment and Molecular Marker Exploration of Locally Recurrent Colorectal Cancer

October 28, 2023 updated by: ZHENGZHAOXU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
This study intends to explore the clinicopathological characteristics and survival prognosis of locally recurrent colorectal cancer patients with different treatment modes by retrospectively analyzing the medical records of locally recurrent colorectal cancer patients who received hospitalization in our center. Transcriptome sequencing and public databases were used to screen for molecular markers related to locally recurrent colorectal cancer and to explore molecular markers' regulatory role in the progression of locally recurrent colorectal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the past few decades, although the widespread implementation of total mesorectal excision (TME) and neoadjuvant chemoradiotherapy has dramatically reduced the postoperative local recurrence rate of rectal cancer, local recurrence after radical resection of colorectal cancer still affects the long-term survival of patients. One of the main reasons is that the postoperative local recurrence rate in patients with rectal cancer is about 6-10%, while that in colon cancer is about 4-13%. In clinical practice, surgical treatment is the preferred treatment option for patients with locally recurrent colorectal cancer (LRCRC). However, only more than one-third of LRCRC patients can be surgically resected with recurrent lesions. For surgically treatable LRCRC patients, since the recurrent lesions often infiltrate widely, complete resection of the lesions usually requires expanding the scope of surgical resection, and posterior pelvic surgery is needed if necessary. Surgery (PPE) or even total pelvic excision (TPE), the complications, functional impairment, and perioperative death caused by the surgery also affect the patient's near and far prognosis. When there are distant metastases or unresectable recurrent tumors, radical resection is often not feasible, which may result in significant morbidity and mortality, so it is necessary to explore different treatment modalities, especially surgical treatment. What is the impact on LRCRC. The mechanism of local recurrence is usually thought to be caused by insufficient resection margins or the planting of detached tumor cells. Another standard theory is that it is caused by metachronous canceration around the anastomosis.The possible reasons are unstable cell proliferation and epithelial adaptation at the anastomosis site-sexual hyperplasia. Some studies also believe neither theory can explain the higher recurrence rate around the anastomosis, suggesting that it may be due to unique and persistent genetic changes. By reading a large amount of relevant literature, we found that local recurrence is a kind of metastasis or metachronous metastasis. Metastasis is a complex, multi-step process. Current metastasis research mainly focuses on various cancer cells. However, research on the molecular regulatory mechanisms of colorectal cancer metastasis is still limited.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with locally recurrent colorectal cancer who underwent surgery during hospitalization and whose primary surgical pathology was stage II/III.

Description

Inclusion Criteria:

  1. Patients with LRCRC who received hospitalization in our center and patients with stage II-III colorectal cancer whose primary surgery was radical surgery
  2. The pathological type of primary tumor is adenocarcinoma
  3. Postoperative local recurrence of colorectal cancer diagnosed by imaging or pathological examination
  4. Have complete medical records and continuous follow-up records

Exclusion Criteria:

  1. Familial hereditary colorectal malignant tumors
  2. Past history of other malignant tumors
  3. Recurrence and diffuse peritoneal recurrence occurring within 1 month after surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with local recurrence
Procedure: salvage surgery
Some patients who cannot undergo surgery
Other Names:
  • adjuvant treatment
patients without local recurrence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3-years
3-years
Cancer-specific survival
Time Frame: 3-years
3-years

Secondary Outcome Measures

Outcome Measure
Time Frame
Find a differentially expressed gene
Time Frame: 3-years
3-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Chair: Zhaoxu Zheng, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 28, 2023

First Submitted That Met QC Criteria

October 28, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 28, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CancerIHCAMS-NCC4237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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