Metachonous Peritoneal Carcinomatosis Incidence After Curative Surgery for pT4 Colon Cancer Patients

NCT05300789 | Completed

• 1 other identifier: 04/21-4398
• Study Type: observational
• Target: 1,152
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational retrospective cohort study to determine metachronous peritoneal carcinomatosis in a specific subgroup of colon cancer patients, those with a final pathologic exam corresponding to pT4 tumors. Based on a sample size calculation of 1152 patients, a retrospective review of a three year period of every participant hospitals, 50 in total, of different characteristics, was stablished. Demographic, clinical, operative, histologic and oncologic follow-up variables were recorded.

Conditions

Peritoneal Carcinomatosis; Colon Cancer

Keywords

colon cancer; metachronous peritoneal carcinomatosis; epidemiology; risk factors

Outcome Measures

Primary Outcomes (1)

• Metachronous peritoneal carcinomatosis

  Number of patients diagnosed with peritoneal carcinomatosis during regular oncologic follow-up

  A minimum of 3-years follow-up

Secondary Outcomes (1)

• Time to metachronous peritoneal carcinomatosis diagnosis

  A minimum of 3-years follow-up

Study Arms (1)

pT4 colon cancer patients after curative resection

Other: Follow-up

Interventions

Follow-up OTHER

There is no intervention. Patients are just going to be registered and oncologic follow-up data are going to be recorded.

pT4 colon cancer patients after curative resection

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

Adult colon cancer patients operated on with curative intention, both scheduled and emergency surgery, with pathologic confirmation of pT4 tumors.

You may qualify if:

• Colon cancer above 15 cm from anal verge
• Curative intent surgery
• Pathologic confirmation of pT4 adenocarcinoma

You may not qualify if:

• R2 cancer resection
• Pathologic diagnosis of colon cancer other than adenocarcinoma, such as GIST, leiomyosarcomas, neuroendocrine tumors, or other types even more unusual.

Sponsors & Collaborators

• Carlos Cerdán Santacruz: lead
• Spanish Association of Surgeons (AEC): collaborator

Study Sites (1)

Carlos Cerdán

Madrid, Spain

Location

MeSH Terms

Conditions

Peritoneal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant. Colorectal Surgery Department. Principal Investigator

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 29, 2022
• Study Start: March 1, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: From the present moment, during the next 3 years.
• Access Criteria: Under demand and with well documented and reasonable arguments.

Locations

ES (1)