NCT04192539

Brief Summary

Serum taurine results in this study showed that, besides CRC biomarkers; it is most attractive, more precious and more accurate early biomarker for early detecting of any malignant change which may led to CRC by other mean it is the most sensitive and more specific tumor marker for CRC. As a result, we can recommend measuring its level regularly with other prognostic tumor biomarkers and screening examination for all people with abdominal and gastrointestinal problems and for precancerous patients as a pre-early biomarker for colorectal carcinoma. So, it needs further studies to confirm that observations on large scale of population as it obvious the small sample size in early stage and lack data due to limited financial resources and it needs more efforts to collect first and precancerous stages patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 18, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

December 7, 2019

Last Update Submit

December 9, 2019

Conditions

Taurine in Cancer Colon

Outcome Measures

Primary Outcomes (1)

  • serum taurine levels

    8 months

Study Arms (4)

Control

ACTIVE COMPARATOR
Diagnostic Test: Taurine

Inflammation

ACTIVE COMPARATOR
Diagnostic Test: Taurine

Benign group

ACTIVE COMPARATOR
Diagnostic Test: Taurine

Malignant group

ACTIVE COMPARATOR
Diagnostic Test: Taurine

Interventions

TaurineDIAGNOSTIC_TEST

Serum taurine was determined by High Performance Liquid Chromatography (HPLC) according to the pre-column extraction and derivatization methodology of McMahon et al. In the present work, we use Shimadzu HPLC model LC-10AT

Benign groupControlInflammationMalignant group

Eligibility Criteria

Age19 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients complain of abdominal troubles and gastrointestinal problems and bleeding per rectum

You may not qualify if:

  • Patients refusal,non-colonic diseases like; Irritable colon, Gastroenteritis, Pancreatitis, Chronic cholecystitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 7, 2019

First Posted

December 10, 2019

Study Start

January 18, 2017

Primary Completion

February 20, 2018

Study Completion

December 17, 2018

Last Updated

December 11, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)