Colorectal CancerNCT06325410
Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience
An observational study of Colorectal Cancer, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- resection of colorectal cancer
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2013to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Adult patients with newly diagnosed colorectal cancer
- Age > 18 years old
- recurrent cases of colorectal cancer
Who cannot join
- Pediartric patient less than 18 yr
- In operable or metastatic cancer colon
- No other malignancies
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- resection of colorectal cancer
- Keywords
- colorectal, cancer, recurrence, prognosis
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resection of colorectal cancerProcedure or surgery
resection of bowel segment and re-anastmosis or stoma formation
What is being measured
The primary outcome is the main question the study is designed to answer.
age
age of patients was obtained from medical records
Measured: through study completion, an average of 5 years
sex
sex of patients was obtained from medical records
Measured: through study completion, an average of 5 years
medical disease
co-existing medical disease was obtained from medical records
Measured: through study completion, an average of 5 years
previous surgery
previous surgical history was obtained from medical records
Measured: through study completion, an average of 5 years
CEA
value of carcino-embryonic antigen was recorded
Measured: through study completion, an average of 5 years
tumor grade
tumor grade after resection from pathology report recorded
Measured: through study completion, an average of 5 years
tumor site
tumor site recorded from operative findings
Measured: through study completion, an average of 5 years
tumor size
tumor size was measured by length x width in cm from records
Measured: 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)
Measured: through study completion, an average of 5 years
neoadjuvant therapy
history of neoadjuvant therapy before surgery from records obtained
Measured: through study completion, an average of 5 years
adjuvant therapy
history of adjuvant therapy post operative obtained from records
Measured: through study completion, an average of 5 years
diet
diet and dietary life style from history
Measured: through study completion, an average of 5 years
occupation
occupation of the patient at time of surgery and if it was changed
Measured: through study completion, an average of 5 years
family history
history taking of family history of cancer disease
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 5 years
post operative complications
from records; if there were post operative complication like fecal fistula
Measured: through study completion, an average of 5 years
site of recurrence
site of tumor recurrence was detected
Measured: through study completion, an average of 5 years
type of resected tumor
type of tumor was recorded from pathology reports
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study startJan 2013
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
- Investigators
- Reham Zakaria, PhD, Principal investigator, faculty of medicine Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325410
- Sponsor's protocol ID
- #11279-20-11-2023
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be available on demand by contacting the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience
- ClinicalTrials.gov ID
- NCT06325410
- Acronym / sponsor ID
- #11279-20-11-2023
- Conditions
- Colorectal Cancer
- Keywords
- colorectal, cancer, recurrence, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Adult patients with newly diagnosed colorectal cancer
- Age > 18 years old
- recurrent cases of colorectal cancer
Key exclusion criteria (3 listed)
- Pediartric patient less than 18 yr
- In operable or metastatic cancer colon
- No other malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resection of colorectal cancerresection of bowel segment and re-anastmosis or stoma formation | Procedure or surgery | – |
Primary outcome
age
Time frame: through study completion, an average of 5 years
age of patients was obtained from medical records
sex
Time frame: through study completion, an average of 5 years
sex of patients was obtained from medical records
medical disease
Time frame: through study completion, an average of 5 years
co-existing medical disease was obtained from medical records
previous surgery
Time frame: through study completion, an average of 5 years
previous surgical history was obtained from medical records
CEA
Time frame: through study completion, an average of 5 years
value of carcino-embryonic antigen was recorded
tumor grade
Time frame: through study completion, an average of 5 years
tumor grade after resection from pathology report recorded
tumor site
Time frame: through study completion, an average of 5 years
tumor site recorded from operative findings
tumor size
Time frame: through study completion, an average of 5 years
tumor size was measured by length x width in cm from records
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)
neoadjuvant therapy
Time frame: through study completion, an average of 5 years
history of neoadjuvant therapy before surgery from records obtained
adjuvant therapy
Time frame: through study completion, an average of 5 years
history of adjuvant therapy post operative obtained from records
diet
Time frame: through study completion, an average of 5 years
diet and dietary life style from history
occupation
Time frame: through study completion, an average of 5 years
occupation of the patient at time of surgery and if it was changed
family history
Time frame: through study completion, an average of 5 years
history taking of family history of cancer disease
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
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
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
post operative complications
Time frame: through study completion, an average of 5 years
from records; if there were post operative complication like fecal fistula
site of recurrence
Time frame: through study completion, an average of 5 years
site of tumor recurrence was detected
type of resected tumor
Time frame: through study completion, an average of 5 years
type of tumor was recorded from pathology reports
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No. data will be available on demand by contacting the principle investigator
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham Zakaria, PhD principal investigator
faculty of medicine Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
age (time frame: through study completion, an average of 5 years). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.