| CTRI Number |
CTRI/2020/10/028762 [Registered on: 29/10/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study That Correlates The Diversity Of Micro-Organisms In Rectum Of Rectal Cancer Patients With The Clinical And Pathological Variables Of The Patient. |
|
Scientific Title of Study
|
Clinico Pathological Correlation Of Diversity And Quantity Of Rectal Microbiota In Rectal Cancer Patients - A Metagenome Analysis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandramohan K |
| Designation |
Additional Professor |
| Affiliation |
Regional Cancer Centre, Trivandrum. |
| Address |
Dept. Of Surgical Oncology, RCC Trivandrum.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9895774393 |
| Fax |
|
| Email |
dr.chandramohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandramohan K |
| Designation |
Additional Professor |
| Affiliation |
Regional Cancer Centre, Trivandrum. |
| Address |
Dept. Of Surgical Oncology, RCC Trivandrum.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9895774393 |
| Fax |
|
| Email |
dr.chandramohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jino Sebastian |
| Designation |
Mch Surgical Oncology Trainee |
| Affiliation |
Regional Cancer Centre Trivandrum |
| Address |
Dept. of Surgical Oncology, RCC Trivandrum.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9496829467 |
| Fax |
|
| Email |
jinosebastian27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Surgical Oncology, old building, 4 th floor, Regional Cancer Centre, Trivandrum, kerala, india |
|
|
Primary Sponsor
|
| Name |
Regional Cancer CentreTrivandrum |
| Address |
Regional Cancer Centre, Trivandrum, Kerala |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jino Sebastian |
Regional Cancer Centre |
Division of Chest and Gastro Oncology, Dept of surgical oncology, 4th floor, old building.
Thiruvananthapuram
KERALA |
09496829467
jinosebastian27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee, RCC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis was confirmed by biopsy and histologic analysis |
|
| ExclusionCriteria |
| Details |
1. Intestinal obstruction
2. Received Bowel preparation within past 14 days
3. Patients received preoperative chemotherapy or radiation therapy
4. Known lactose intolerance
5. Immunodeficiency
6. Inflammatory bowel disease
7. Received antibiotics with in past 3 months before sample collection
8. Evidence of infection
9. Probiotics or prebiotics usage within 2 weeks |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the pattern and diversity of colonic microbiota in rectal cancer patients.
To correlate clinico-pathological variables to colonic microbiota in rectal cancer patients
|
At one month, six month and 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the influence of colonic microbiota in immediate outcome of surgical treatment in rectal cancer patients
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Colorectal cancer (CRC) , is the third most common cancer in the world. The human gastrointestinal tract harbors approximately 1000 species of bacteria totaling 1014 cells, which is more than 10-fold the number of eukaryotic human cells . At present, there is substantial evidence suggesting that several environmental factors markedly affect the intestinal microbiota composition . And there is unequivocal evidence linking gut dysbiosis to CRC development. Accumulated studies show that several bacterial species seem to involve in pathogenesis of CRC , Streptococcus Gallolyticus (Formerly Streptococcus bovis) is present approximately 20–50% of colon tumors and less than 5% in the normal colon. Fusobacterium nucleatum is found over- represented in tumour micro-environment.
The exact composition of intestinal microbiota and its function in CRC progression remain unknown because the overall structure of microbiota in CRC patients has not been completely elucidated. Higher tissue and faecal concentrations of the bacteria have been associated with the later stages of CRC. In this study we are looking into the quantity and diversity of microbiota in rectal cancer patients and its correlation with tumour stage.
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