| CTRI Number |
CTRI/2021/01/030418 [Registered on: 13/01/2021] Trial Registered Prospectively |
| Last Modified On: |
20/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Vitamin-D, Vitamin-B12, Folic acid(Essential vitamins involved in body metabolism) and Beta-hCG(a hormone which is related to pregnancy) levels in benign(not dangerous) and malignant(cancerous) breast disease |
|
Scientific Title of Study
|
Vitamin-D, Vitamin-B12, Folic acid and Beta-hCG profile in patients with benign and malignant breast disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranjith Kumaran R |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of General Surgery, Office room no.14, Trauma center, U.P. University of Medical Sciences, Saifai, Etawah, U.P.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
09487555545 |
| Fax |
|
| Email |
ranjithkumaran2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shailendra Pal Singh |
| Designation |
Senior grade Professor and head |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of General Surgery, Office room no.14, Trauma center, U.P. University of Medical Sciences, Saifai, Etawah, U.P.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
09457879726 |
| Fax |
|
| Email |
drspsinghsaifai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ranjith Kumaran R |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of General Surgery, Office room no.14, Trauma center, U.P. University of Medical Sciences, Saifai, Etawah, U.P.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
09487555545 |
| Fax |
|
| Email |
ranjithkumaran2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences, Saifai, Etawah, U.P. |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences |
| Address |
Saifai, Etawah, U.P. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Ranjith Kumaran R |
Uttar Pradesh University of Medical Sciences |
Department of General Surgery, Office room no.14, Trauma center, U.P. University of Medical Sciences, Saifai, Etawah, U.P.
Etawah
UTTAR PRADESH |
09487555545
ranjithkumaran2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Uttar Pradesh University of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, (2) ICD-10 Condition: E538||Deficiency of other specified B group vitamins, (3) ICD-10 Condition: C50||Malignant neoplasm of breast, (4) ICD-10 Condition: E559||Vitamin D deficiency, unspecified, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Female patients with Benign and malignant breast diseases diagnosed by histopathological examination. |
|
| ExclusionCriteria |
| Details |
Females with pre existing comorbidities.
Patients on Vitamin-D, Vitamin-B12 and/or Folic acid supplements.
Patients who are undergoing or had previously undergone cancer chemotherapy.
Patients with history of gastrointestinal surgery.
Patients not giving consent to be part of the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| THE PRIMARY OBJECTIVE IS TO FIND THE ASSOCIATION OF BENIGN AND MALIGNANT BREAST DISEASES WITH DERANGED CIRCULATING SERUM LEVELS OF VITAMIN-D, VITAMIN-B12, FOLIC ACID AND BETA-hCG. |
AT BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO DRAW AN ASSOCIATION BETWEEN DIETARY AND NUTRITIONAL DEFICIENCIES IN THE PATHOGENESIS OR CAUSATION OF BENIGN AND MALIGNANT BREAST DISEASES IN INDIAN WOMEN. |
AT BASELINE |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "91"
Final Enrollment numbers achieved (India)="91" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2021 |
| Date of Study Completion (India) |
25/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a prospective, cross-sectional, observational study aimed at finding the association of benign and malignant breast diseases with deranged circulating serum levels of the important bodily vitamins such as Vitamin-D, Vitamin-B12, Folic acid and also to correlate with the circulating serum levels of Beta-hCG. The primary objective is to draw a correlation between the dietary and nutritional factors involved in the pathogenesis or causation of benign and malignant breast diseases in Indian women. |