NCT06884839

Brief Summary

This study aims to evaluate the tumor deposits in colorectal cancer and its prognostic value in survival and metastasis

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

March 13, 2025

Last Update Submit

March 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients' overall survival

    Patients' overall survival (OS) is defined as from colorectal cancer (CRC) diagnosis to death.

    2 years postoperatively

Secondary Outcomes (1)

  • Distant metastasis

    2 years postoperatively

Study Arms (1)

Therapeutic resection group

Patients with colorectal cancer underwent therapeutic resection with pathologically positive tumor deposits (TDs) to determine distant metastasis occurrence and the effect of TDs on survival.

Procedure: Therapeutic resection

Interventions

Patients with colorectal cancer underwent therapeutic resection with pathologically positive tumor deposits (TDs) to determine distant metastasis occurrence and the effect of TDs on survival.

Therapeutic resection group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This prospective and retrospective study will be conducted on 30 patients with colorectal cancer.

You may qualify if:

  • Age above 18 years old.
  • Both sexes.
  • All Colorectal cancer patients From Stage I to III Colorectal cancer with pathologically positive Tumor deposits.

You may not qualify if:

  • Patient took neoadjuvant therapy.
  • No information available on tumor deposits.
  • Colorectal cancer is not the only primary cancer.
  • Patients with incomplete information about follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, 61611, Egypt

RECRUITING

MeSH Terms

Conditions

Extranodal ExtensionColorectal NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Abdelrahman M Salah, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt.

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 19, 2025

Study Start

August 1, 2022

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations