Prognostic Factors Affecting Recurrence and Disease-Free Survival After Surgical Resection for Cancer Rectum
October 21, 2023 updated by: Abdallah Mohamed Taha Aly, South Valley University
Predictors of Disease Free Survival After Curative Cancer Rectum Surgery
Tumor recurrence after curative surgical resection for rectal cancer is a serious complication that greatly affects the overall morbidity and the outcome.
This study aims to identify the different prognostic factors affecting recurrence and disease-free survival after surgery.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A retrospective analysis of patients operated for cancer rectum with curative intent from.
Exclusion criteria will include patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, and death within 3 months. Incomplete patients' files and patients that lost follow-up will be excluded.
Demographic, histopathological, follow up and outcome data will be collected from completed patients' files. Demographics include age, gender, family history, and chief complaint at the presentation. Histopathological data include tumor grade, vascular-perineural invasion, the total number of lymph nodes removed, and positive lymph nodes.
Lymph node ratio will be defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in a histopathology specimen. Disease-free survival will be calculated for each patient based on the time of surgery to the time of recurrence detection.
Study Type
Observational
Enrollment (Estimated)
200
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
- Name: Abdallah M Taha, MD
- Phone Number: +201011716497
- Email: abdallahsurgery@med.svu.edu.eg
Study Locations
-
-
-
Qinā, Egypt
- Recruiting
- Qena Faculty of Medicine, South Valley University Hospitals
-
Contact:
- Abdallah M Taha, MD
- Phone Number: +201011617497
- Email: abdallahsurgery@med.svu.edu.eg
-
Principal Investigator:
- Abdallah M Taha, MD
-
-
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
N/A
Sampling Method
Non-Probability Sample
Study Population
- Patients who had curative surgery for cancer rectum.
Description
Inclusion Criteria:
- Patients who had curative surgery for cancer rectum.
Exclusion Criteria:
- Patients with familial adenomatous polyposis (FAP), multiple synchronous or metachronous rectal cancers, and death within 3 months
- Patients that lost follow-up will be excluded.
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 cancer rectum underwent curative surgery
|
Curative surgery for cancer rectum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tumor recurrence
Time Frame: Through study completion, an average of 3 year
|
Presence of Tumor recurrence after curative surgery for cancer rectum.
|
Through study completion, an average of 3 year
|
|
Disease free survival.
Time Frame: up to 5 years
|
From date of surgery until the date of recurrence detection.
|
up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abdallah M Taha, MD, South Valley University, Egypt.
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
- Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.
- Li Destri G, Di Carlo I, Scilletta R, Scilletta B, Puleo S. Colorectal cancer and lymph nodes: the obsession with the number 12. World J Gastroenterol. 2014 Feb 28;20(8):1951-60. doi: 10.3748/wjg.v20.i8.1951.
- Hashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T, Hasegawa K, Hotta K, Ishida H, Ishiguro M, Ishihara S, Kanemitsu Y, Kinugasa Y, Murofushi K, Nakajima TE, Oka S, Tanaka T, Taniguchi H, Tsuji A, Uehara K, Ueno H, Yamanaka T, Yamazaki K, Yoshida M, Yoshino T, Itabashi M, Sakamaki K, Sano K, Shimada Y, Tanaka S, Uetake H, Yamaguchi S, Yamaguchi N, Kobayashi H, Matsuda K, Kotake K, Sugihara K; Japanese Society for Cancer of the Colon and Rectum. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol. 2020 Jan;25(1):1-42. doi: 10.1007/s10147-019-01485-z. Epub 2019 Jun 15.
- He WZ, Xie QK, Hu WM, Kong PF, Yang L, Yang YZ, Jiang C, Yin CX, Qiu HJ, Zhang HZ, Zhang B, Xia LP. An increased number of negative lymph nodes is associated with a higher immune response and longer survival in colon cancer patients. Cancer Manag Res. 2018 Jun 18;10:1597-1604. doi: 10.2147/CMAR.S160100. eCollection 2018.
- Tschmelitsch J, Kronberger P, Glaser K, Klingler A, Bodner E. Survival after surgical treatment of recurrent carcinoma of the rectum. J Am Coll Surg. 1994 Jul;179(1):54-8.
- Feeney G, Sehgal R, Sheehan M, Hogan A, Regan M, Joyce M, Kerin M. Neoadjuvant radiotherapy for rectal cancer management. World J Gastroenterol. 2019 Sep 7;25(33):4850-4869. doi: 10.3748/wjg.v25.i33.4850.
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)
May 1, 2023
Primary Completion (Estimated)
November 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
October 19, 2023
First Submitted That Met QC Criteria
October 21, 2023
First Posted (Actual)
October 23, 2023
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 21, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SVU-MED-SUR011-4-23-4-621
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.