NCT05779553

Brief Summary

Aim of work

  1. 1.measurement level of serumTEM1 in CRC patients by ng/ml using ELISA kits .
  2. 2.find relation between serum TEM1 level and staging of CRC patients .
  3. 3.measurement of serum CEA , CA19-9 levels by ng/ml so we can can compare their levels with serum TEM1 level in CRC patients .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started May 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
May 2023Dec 2026

First Submitted

Initial submission to the registry

January 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

January 14, 2023

Last Update Submit

March 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tumor endothelial marker 1 in colorectal cancer

    1. measurement level of serumTEM1 in CRC patients by ng/ml using ELISA kits . 2. measurement of serum CEA , CA19-9 levels by ng/ml

    baseline

Study Arms (2)

Group (1)(patient group):

who are 50 newly diagnosed patient with colorectal cancer, who will be admitted at South Egypt Cancer Inistitute and Assiut University Hospital during 2023. Patients group will be furtherly subclassified according to the American Joint Committee on Cancer Staging,TNM staging classification

Diagnostic Test: Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kits

Group (2) (control group)

40 apparently healthy individuals with matched age and sex are included in this study as a control group for comparison.

Diagnostic Test: Tumor Endothelial Marker 1 ( TEM1 ) by ELISA kits

Interventions

measurement of serum TEM1 in CRC patients, its relation to staging and comparing the diagnostic performance of serum TEM1 with serum CEA and CA19-9 for diagnosis of CRC. and Early detection of CRC patient

Group (1)(patient group):Group (2) (control group)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Fifty patients who were diagnosed by (lower endoscopy, multislice CT abdomen or histopathology analysis of the lesion), tumor staging was classified according to the American Joint Committee on Cancer Staging,TNM staging classification. * Patients did not receive any chemotherapy or undergo surgical treatment * Forty apparently healthy individuals with matched age and sex are included in this study as a control group for comparison

You may qualify if:

  • newly diagnosed CRC patients.

You may not qualify if:

  • chemotherapy
  • radiotherapy
  • surgical treatment
  • heart failure
  • angina
  • liver cirrhosis
  • renal cell carcinoma
  • gastric cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Esraa Emad Abdel Azeem Kamel, master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assiut lecturer

Study Record Dates

First Submitted

January 14, 2023

First Posted

March 22, 2023

Study Start

May 1, 2023

Primary Completion

February 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 22, 2023

Record last verified: 2023-03