- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06325410
Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zagazig, Egypt, 44519
- Zagazig University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients with newly diagnosed colorectal cancer
- Age > 18 years old
- recurrent cases of colorectal cancer
Exclusion Criteria:
- Pediartric patient less than 18 yr
- In operable or metastatic cancer colon
- No other malignancies
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
age
Time Frame: through study completion, an average of 5 years
|
age of patients was obtained from medical records
|
through study completion, an average of 5 years
|
sex
Time Frame: through study completion, an average of 5 years
|
sex of patients was obtained from medical records
|
through study completion, an average of 5 years
|
medical disease
Time Frame: through study completion, an average of 5 years
|
co-existing medical disease was obtained from medical records
|
through study completion, an average of 5 years
|
previous surgery
Time Frame: through study completion, an average of 5 years
|
previous surgical history was obtained from medical records
|
through study completion, an average of 5 years
|
CEA
Time Frame: through study completion, an average of 5 years
|
value of carcino-embryonic antigen was recorded
|
through study completion, an average of 5 years
|
tumor grade
Time Frame: through study completion, an average of 5 years
|
tumor grade after resection from pathology report recorded
|
through study completion, an average of 5 years
|
tumor site
Time Frame: through study completion, an average of 5 years
|
tumor site recorded from operative findings
|
through study completion, an average of 5 years
|
tumor size
Time Frame: through study completion, an average of 5 years
|
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
Time Frame: through study completion, an average of 5 years
|
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
Time Frame: through study completion, an average of 5 years
|
history of neoadjuvant therapy before surgery from records obtained
|
through study completion, an average of 5 years
|
adjuvant therapy
Time Frame: through study completion, an average of 5 years
|
history of adjuvant therapy post operative obtained from records
|
through study completion, an average of 5 years
|
diet
Time Frame: through study completion, an average of 5 years
|
diet and dietary life style from history
|
through study completion, an average of 5 years
|
occupation
Time Frame: through study completion, an average of 5 years
|
occupation of the patient at time of surgery and if it was changed
|
through study completion, an average of 5 years
|
family history
Time Frame: through study completion, an average of 5 years
|
history taking of family history of cancer disease
|
through study completion, an average of 5 years
|
type of surgery(laparoscopic or open)
Time Frame: through study completion, an average of 5 years
|
type of operation was laparoscopic or open surgery obtained from records
|
through study completion, an average of 5 years
|
soiling by during surgery
Time Frame: through study completion, an average of 5 years
|
by history from records if there was soiling of the field by tumor cells
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through study completion, an average of 5 years
|
hand sewen or stappled anastmosis
Time Frame: through study completion, an average of 5 years
|
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
Time Frame: through study completion, an average of 5 years
|
from records; if there were post operative complication like fecal fistula
|
through study completion, an average of 5 years
|
site of recurrence
Time Frame: through study completion, an average of 5 years
|
site of tumor recurrence was detected
|
through study completion, an average of 5 years
|
type of resected tumor
Time Frame: through study completion, an average of 5 years
|
type of tumor was recorded from pathology reports
|
through study completion, an average of 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Reham Zakaria, PhD, faculty of medicine Zagazig University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #11279-20-11-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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