| CTRI Number |
CTRI/2024/10/075954 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measuring levels of pesticides in Breast Cancers. |
|
Scientific Title of Study
|
Pesticide Measurement in Breast Cancer Tissue |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krithikaa Sekhar |
| Designation |
Consultant, Radiation Oncology |
| Affiliation |
HealthCare Global Enterprises Ltd. |
| Address |
Department of Radiation Oncology, Tower 2, First Floor, room no 1, HCG Towers, 8, P. Kalinga Rao Road, Sampangi Ram Nagar
Bangalore
KARNATAKA
560027
India |
| Phone |
9600455254 |
| Fax |
|
| Email |
drkrithikaa.s@hcgel.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krithikaa Sekhar |
| Designation |
Consultant, Radiation Oncology |
| Affiliation |
HealthCare Global Enterprises Ltd. |
| Address |
Department of Radiation Oncology, Tower 2, First Floor, room no 1, HCG Towers, 8, P. Kalinga Rao Road, Sampangi Ram Nagar
KARNATAKA
560027
India |
| Phone |
9600455254 |
| Fax |
|
| Email |
drkrithikaa.s@hcgel.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krithikaa Sekhar |
| Designation |
Consultant, Radiation Oncology |
| Affiliation |
HealthCare Global Enterprises Ltd. |
| Address |
Department of Radiation Oncology, Tower 2, First Floor, room no 1, HCG Towers, 8, P. Kalinga Rao Road, Sampangi Ram Nagar
KARNATAKA
560027
India |
| Phone |
9600455254 |
| Fax |
|
| Email |
drkrithikaa.s@hcgel.com |
|
|
Source of Monetary or Material Support
|
| HealthCare Global Enterprises Ltd, HCG Towers, 8, P Kalinga Rao Road, Sampangi Ram Nagar, Benagaluru, 560027, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
HealthCare Global Enterprises Ltd. |
| Address |
8, P. Kalinga Rao Road, Sampangi Ram Nagar |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Krithikaa Sekar |
HealthCare Global Enterprises Ltd. |
Department of Radiation Oncology, Tower 2, First Floor, room no 1, HCG Towers, 8, P. Kalinga Rao Road, Sampangi Ram Nagar
Bangalore
KARNATAKA |
9600455254
krithikaa.s@hcgel.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HCG -Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Pathologically confirmed Breast cancers of all morphologies |
|
| ExclusionCriteria |
| Details |
Non malignant breast tumors |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Presence or absence of pesticides in the breast tissue |
One time at the time of sampling |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Component analyses of pesticides |
one time, at the time of sampling |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
15/11/2024 |
| 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="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Recurrent inflammation caused by any carcinogenic agent such as bacteria, virus, -Tobacco or pesticide is the underlying pathophysiology of cancer formation.
Inflammation caused by obesity is a major attributor of breast carcinoma. -However, the influence of local accumulation of Pesticides-an inflammatory carcinogenic agent that specifically has affinity for fatty tissue is underlooked. - Food items such as poultry, fish, meat, and dairy products serve as sources of exposure for these pesticides through the diet. It is also secreted in cow’s milk and human breast milk,and has been detected in household dust and air. - Oc tend to accumulate in adipose tissue when compared with blood, and breast samples predict the level of oc exposed over time. |