Tumor Deposits in Cancer Colon

March 3, 2021 updated by: Naglaa Fathi Mosa, Assiut University

Evaluation of the Role of Tumor Deposits on the Prognosis of Colorectal Carcinoma

  1. Assessment of correlation between tumor deposits and clinicopathological characteristics of colorectal cancer.
  2. Detection of association between tumor deposits and stage of colorectal cancer.
  3. Evaluate the relationship between tumor deposits and prognosis of colorectal cancer patient.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Colorectal cancer remains the third most common cancer and the third leading cause of cancer-related deaths. For colon cancer alone, 101,220 new cases were projected to occur in 2019, causing51,020 deaths.

A number of risk factors have been identified that influence susceptibility to colorectal cancer, including a family history, the presence of adenomatous polyps, inflammatory bowel disease (ulcerative colitis or Crohn's disease), and number of environmental factors of which diet is the most significant.

CRC differs from many other cancers in that diagnosis of the disease can be made earlier by screening techniques including colonoscopy. The progression of CRC is well established and begins with hyperproliferation of the colonic mucosa and adenoma formation and then adenocarcinomas that vary in metastatic potential.

The progression from normal intestinal epithelium to an invasive carcinoma is estimated to take 7-12 years. With the advent of early screening measures developed over the last few decades, CRC has become a preventable disease by treating patients with adenomatous polyps. Nearly 50% of patients diagnosed with CRC develop metastasis within five years. Most commonly these tumors metastasize to the liver and lungs but may be discovered in many other sites.

Despite significant improvements in both prevention and screening over the last twenty years, about 36,500 (36%) of such cases are still being diagnosed in stage III, with regional lymph node involvement (LN+, N1a-b, N2a-b) or tumor deposits (TD+, N1c).

Tumor deposits (TDs) or mesenteric tumor satellites were firs described in rectal carcinoma by Gabriel et al at St. Mark's Hospital in 1935. Subsequently, TDs have been detected in various malignancies other than colorectal carcinoma, including gastric, pancreatic, gallbladder, and bile duct carcinomas . Over the years, there is much debate about the genesis, histopathologic characteristics, and prognostic value of TDs.

TDs are associated with advanced colorectal carcinoma stage and poor prognosis, with variable outcome due to different definitions of TDs.

Before the 5th edition, published in 1997, TNM classification did not consider microscopic TDs to be lymph node metastases (LNMs), and they classified them as discontinuous extension in the T category .

In the 5th TNM edition the 3-mm rule was introduced, which stated that TDs >3mm in diameter were LNMs .

In the 6th edition published in 2002, TDs were classified based on the contour of the deposit. A TD with a smooth contour was considered as LMN, whereas a TD with an irregular contour was considered as venous invasion (V1/2) or lymphatic invasion (L1).

The 8th TNM Edition clarified that the presence of TDs does not change the primary tumor T category, but changes the node status (N) to pN1c if all regional lymph nodes are negative on pathological examination.

In studies of rectal cancer patients, it should be taken into account that TDs may indicate microscopic residuals of the main tumor after neoadjuvant chemo radiation and not discontinuous foci of tumor as indicated in the classic definition of TDs.

The presence of TDs was an independent adverse prognostic factor that was significantly associated with shorter disease-free survival independent of lymph node status in stage IV colorectal cancer patients who underwent simultaneous resection for synchronous colorectal liver metastases.

After chemo-radiotherapy, rectal cancer is usually associated with small clusters of tumor cells or isolated tumor cells, scattered within or outside the rectal wall which are often associated to fibrosis and chronic inflammation, as well as other radiation induced changes. The prognostic significance of TDs in rectal adenocarcinoma following neoadjuvant chemoradiation has not yet been determined, although this remains an important issue given that patients who receive neoadjuvant chemoradiation have more advanced tumors and the highest risk of distant and local recurrences.

TDs were associated with higher rates of lymph node involvement, distant metastases and reduced survival; more over TDs are associated with aggressive characteristics, including higher rates of positive circumferential resection margins.

Study Type

Observational

Enrollment (Anticipated)

100

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 Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. This retrospective study includes primary invasive colorectal carcinoma samples from Egyptian patients that will be retrieved from the registry of Pathology department, South Egypt Cancer Institute and Assiut University Hospital.
  2. All patients who underwent resection of colorectal cancer will be included in our study.

Description

Inclusion Criteria:

- 1-This retrospective study includes primary invasive colorectal carcinoma samples from Egyptian patients.

2-Patients who underwent resection of colorectal cancer will be included in our study.

Exclusion Criteria:

  • 1-All patients who underwent endoscopic biopsies

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the relationship between tumor deposits and prognosis of colorectal cancer patient.
Time Frame: 2 years
  1. Assessment of correlation between tumor deposits and clinicopathological characteristics of colorectal cancer.
  2. Detection of correlation between tumor deposits and stage of colorectal cancer.
  3. Correlation between tumor deposits and prognosis of colorectal cancer, clinicopathological characteristics of colorectal cancer, stage of colorectal cancer".
2 years

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Not yet

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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