Clinical trial NCT06096493: Prognostic Factors Affecting Recurrence and Disease-Free Survival After Surgical Resection for Cancer Rectum
Official title: Predictors of Disease Free Survival After Curative Cancer Rectum Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Keywords: cancer rectum
recurrence
disease free survival
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients who had curative surgery for cancer rectum.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tumor recurrence
timeFrame: Through study completion, an average of 3 year
measure: Disease free survival.
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Qena Faculty of Medicine, South Valley University Hospitals
Study officials:
affiliation: South Valley University, Egypt.
name: Abdallah M Taha, MD
role: PRINCIPAL_INVESTIGATOR
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