The Prospect of Using Serum Taurine Level as a Potential Biomarker for Early Detection of Colorectal Carcinoma and Its Correlation With Other Prognostic Markers

NCT ID: NCT04192539

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-18

Study Completion Date

2018-12-17

Brief Summary

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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.

Detailed Description

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Two-hundred and fifty Egyptian patients (males and females) who attended National Cancer Institute, Cairo university; most of them were referred from private clinics and non-specialized hospitals, complain with abdominal troubles and gastrointestinal problems and bleeding per rectum, after full investigation, clinical examination, biochemical analysis, screening examination according to their cases (Ultra sound, CT or endoscopy either rectal or colonoscopy) and histopathological examination, we choose 'after their approval' one-hundred patients and six which diagnosed as CRC patients aged (19-69 years old) and excluded the others from participated in these studies because they diagnosed as non-colonic diseases like; Irritable colon, Gastroenteritis, Pancreatitis, Liver flexure or Chronic cholecystitis. According to Histopathological architecture, we divided patients to:

1. Inflammatory group number=7.
2. Benign tumor group number=8 which was assessed preoperatively and postoperatively.
3. Malignant tumor group number=91 Lastly, ten health volunteers were enrolled as a frank control. For all included subjects, the measured biochemical analysis were CBC, ALT, AST, Albumin, Total Bilirubin, Creatinine, Blood urea, Sodium, Potassium, CEA, CA19.9 and Taurine.

Conditions

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Taurine in Cancer Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Taurine

Intervention Type DIAGNOSTIC_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

Inflammation

Group Type ACTIVE_COMPARATOR

Taurine

Intervention Type DIAGNOSTIC_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 group

Group Type ACTIVE_COMPARATOR

Taurine

Intervention Type DIAGNOSTIC_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

Malignant group

Group Type ACTIVE_COMPARATOR

Taurine

Intervention Type DIAGNOSTIC_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

Interventions

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Taurine

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Patients refusal,non-colonic diseases like; Irritable colon, Gastroenteritis, Pancreatitis, Chronic cholecystitis
Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Hanaa Mohamed Abdallah ElGendy MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FWA00007284

Identifier Type: -

Identifier Source: org_study_id