| CTRI Number |
CTRI/2025/07/090828 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Capacity Building Project |
| Study Design |
Other |
|
Public Title of Study
|
Cystic Fibrosis India Expansion Project: Improving Diagnosis and Care for Children with Cystic Fibrosis in Hospitals Across South India |
|
Scientific Title of Study
|
Cystic Fibrosis–India Expansion Project: Expanding and Establishing CF Diagnostics and Clinical Care in Secondary Medical Centers in South India. |
| 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 Sneha Deena Varkki |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Paediatric Unit 3 Office ISSCC Building Ida Scudder Road, Christian Medical College Vellore TAMIL NADU 632004 India |
| Phone |
9597076124 |
| Fax |
|
| Email |
snehatitus85@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sneha Deena Varkki |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Paediatric Unit 3 Office ISSCC Building Ida Scudder Road, Christian Medical College Vellore TAMIL NADU 632004 India |
| Phone |
9597076124 |
| Fax |
|
| Email |
snehatitus85@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sneha Deena Varkki |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Paediatric Unit 3 Office ISSCC Building Ida Scudder Road, Christian Medical College Vellore TAMIL NADU 632004 India |
| Phone |
04162283343 |
| Fax |
|
| Email |
snehatitus85@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Cystic Fibrosis Foundation Grant
4550 Montgomery Ave. Suite 1100N, Bethesda, MD 20814, USA. |
|
|
Primary Sponsor
|
| Name |
Cystic Fibrosis Foundation |
| Address |
4550 Montgomery Ave. Suite 1100N, Bethesda, MD 20814, USA |
| Type of Sponsor |
Other [Non Profit Organisation] |
|
|
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 Sneha Deena Varkki |
Christian Medical College |
Department of Paediatrics Unit - 3
ISSCC building - 5th Floor
Ida Scudder Road Vellore TAMIL NADU |
9597076124
snehatitus85@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Office of Research Christian Medical College Vellore India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
This project involves teaching how to do diagnostic test for Cystic Fibrosis to the lab staff in Five Centres across India. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
This is not a clinical trial. This is a Capacity building project - To equip Five centres across India.
Inclusion criteria:
Any children with suspected CF or Bronchiectasis for evaluation
Exclusion criteria:
Severe dermatitis |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This is a service and educational project
1. Participation in the International Mentoring Training Initiative (IMTI) on Online module
2. Purchase and effective use of sweat testing equipment. |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Purchase & effective use of sweat testing equipment. |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="5" Sample Size from India="5"
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)
|
01/08/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is not a research project. This is a capacity building project funded by the foreign agency. The grant money will be used for purchasing sweat testing equipment, which will be donated to 5 centres across India. The lab staff will be trained to do sweat testing to diagnose CF. This CTRI submission is being done as it was suggested by Health Ministry Screening Committee - The proposal ID 2025-18223 dated 30th June.
Cystic Fibrosis is a life limiting genetic disease which affects people of all races. It was considered an European disease and very little importance was given to this condition in medical education as well as in hospital practice in India. Diagnostic facility for doing sweat chloride testing -gold standard test for the disease is available only in a handful of centres in India. This leads to mis diagnosis or late diagnosis of CF resulting in severe morbidity and childhood mortality. In the last 10 years , significant strides have been made in the care of persons with CF ( pwCF ) in India through coordinated efforts of IAP and many Paediatric pulmonologists in the country. CMC has collaborated with Nationwide Children’s Hospital, Columbus (NCH) and focused on 1) capacity building, 2) training multidisciplinary teams, 3) enhancing education and awareness on CF among healthcare providers and families, and 4) developing cost-effective treatment strategies. Multiple small CF teams or individual doctors serve as core clinical and educational resources in South India and regions in Northeast India, achieving meaningful improvements in diagnostic and clinical outcomes despite various socio-economic and infrastructural challenges. Experience from these collaborations have emphasized the need to enhance regional access to testing and treatment for CF by establishing better diagnostic and clinical care centers.
We, therefore, propose the ‘CF-India Expansion’ plan to identify, develop, and equip five secondary medical centers (SMCs) in South India to become skilled CF care centers with educational and diagnostic resources that would enhance regional CF care. Improved access to diagnostic facilities will facilitate earlier diagnosis and help reduce severe CF-related morbidity and mortality, particularly in young children.
The International Mentoring Training Initiative (IMTI), offered by the International CF Training Network, is designed to prepare U.S.-based CF multidisciplinary teams to mentor CF teams in LMIC. Supported by the CFF and led by the CF team at the University of Alabama/Children’s of Alabama, the IMTI program aims to establish a robust infrastructure for local training at CF care centers across LMIC. As the CF-India expansion plan aims to develop secondary medical centers into skilled CF diagnostic and clinical care facilities, it is essential that these teams receive training and mentorship from established and effective CF centers to achieve competence. |