Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience

NCT06325410 | Completed

• 1 other identifier: #11279-20-11-2023
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

over the past decade colon cancer has emerged as the second most deadly and the third most common type of cancer in the world with increasing incidence in Egypt due to life style and diet change. some research showed relation between colon cancer recurrence and advanced tumor staging. To investigators knowledge, this is the first time to be done in Zagazig University. Data was collected from records in a retrospective cohort study

Conditions

Colorectal Cancer

Keywords

colorectal; cancer; recurrence; prognosis

Outcome Measures

Primary Outcomes (20)

• age

  age of patients was obtained from medical records

  through study completion, an average of 5 years

• sex

  sex of patients was obtained from medical records

  through study completion, an average of 5 years

• medical disease

  co-existing medical disease was obtained from medical records

  through study completion, an average of 5 years

• previous surgery

  previous surgical history was obtained from medical records

  through study completion, an average of 5 years

• CEA

  value of carcino-embryonic antigen was recorded

  through study completion, an average of 5 years

• tumor grade

  tumor grade after resection from pathology report recorded

  through study completion, an average of 5 years

• tumor site

  tumor site recorded from operative findings

  through study completion, an average of 5 years

• tumor size

  tumor size was measured by length x width in cm from records

  through study completion, an average of 5 years

• surgical margins of resected tumor

  safety margins were assessed from pathological examination under microscopy and recorded in pathology reports, it can be free surgical margins ( no tumor cells) or positive surgical margins( presence of tumor cells)

  through study completion, an average of 5 years

• neoadjuvant therapy

  history of neoadjuvant therapy before surgery from records obtained

  through study completion, an average of 5 years

• adjuvant therapy

  history of adjuvant therapy post operative obtained from records

  through study completion, an average of 5 years

• diet

  diet and dietary life style from history

  through study completion, an average of 5 years

• occupation

  occupation of the patient at time of surgery and if it was changed

  through study completion, an average of 5 years

• family history

  history taking of family history of cancer disease

  through study completion, an average of 5 years

• type of surgery(laparoscopic or open)

  type of operation was laparoscopic or open surgery obtained from records

  through study completion, an average of 5 years

• soiling by during surgery

  by history from records if there was soiling of the field by tumor cells

  through study completion, an average of 5 years

• hand sewen or stappled anastmosis

  if there was bowel re-anastmosis after surgery, it was done using a stappler or hand sewing sutures. this was obtained from operative data in patient records

  through study completion, an average of 5 years

• post operative complications

  from records; if there were post operative complication like fecal fistula

  through study completion, an average of 5 years

• site of recurrence

  site of tumor recurrence was detected

  through study completion, an average of 5 years

• type of resected tumor

  type of tumor was recorded from pathology reports

  through study completion, an average of 5 years

Interventions

resection of colorectal cancer PROCEDURE

resection of bowel segment and re-anastmosis or stoma formation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patient with newely diagnosed colorectal cancer were followed up after surgery to detect if there was a recurrence prospectively, while patients with recurrent colorectal cancer were studied retrospectively to find out factors influencing the recurrence

You may qualify if:

• Adult patients with newly diagnosed colorectal cancer
• Age \> 18 years old
• recurrent cases of colorectal cancer

You may not qualify if:

• Pediartric patient less than 18 yr
• In operable or metastatic cancer colon
• No other malignancies

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, 44519, Egypt

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Reham Zakaria, PhD

  faculty of medicine Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 22, 2024
• Study Start: January 1, 2013
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)