| CTRI Number |
CTRI/2024/12/077719 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Clinical validation study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the functioning of menstrual fluid collection Device M-StripTM
|
|
Scientific Title of Study
|
An Open Label Clinical Investigation to Assess and Measure the Functionality of Menstrual Fluid
Collection Device- M- StripTM
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/CLI/MD/006 Version 1.1 & Dated 04NOV2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Somesh Chandra |
| Designation |
Principal Investigator |
| Affiliation |
Sterling Hospital |
| Address |
Room no 1, 2nd Floor, Department of Clinical Research, Sterling Hospital, Sterling Hospital Road, Memnagar, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380052
India |
| Phone |
09426014627 |
| Fax |
|
| Email |
someshchandra@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somesh Chandra |
| Designation |
Principal Investigator |
| Affiliation |
Sterling Hospital |
| Address |
Room no 1, 2nd Floor, Department of Clinical Research, Sterling Hospital, Sterling Hospital Road, Memnagar, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380052
India |
| Phone |
09426014627 |
| Fax |
|
| Email |
someshchandra@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO representative |
| Affiliation |
TrialGuna Private Limited |
| Address |
#467, Room no 1, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
09972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Iota Diagnostic Private Limited, #10 CrAdLE-EDII Institute, Airport Road, Indira Bridge, Gandhinagar,
Gujarat – 382428 |
|
|
Primary Sponsor
|
| Name |
IOTA Diagnostic Private Limited |
| Address |
Iota Diagnostic Private Limited, #10 CrAdLE-EDII Institute, Airport Road, Indira Bridge, Gandhinagar,
Gujarat – 382428 |
| Type of Sponsor |
Other [Research and Product Development] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Somesh Chandra |
Sterling Hospital |
Room no 1, 2nd Floor, Department of Clinical Research, Sterling Hospital, Sterling Hospital Road, Memnagar, Ahmedabad, Gujarat
Ahmadabad
GUJARAT |
09426014627
someshchandra@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sterling Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Female Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Healthy women volunteers are chosen aged 30 and 55 years.
2.Subjects who are willing to participate in the study and sign the
informed consent document and comply with the trial procedure.
3.Subjects who are compliant with the study. |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Clinical evidence of any serious systemic disease or acute illness, in the
clinical opinion of the Investigator.
3.Subjects who are surgically sterile or have attained menopause (if they
had their last menstruation more than 2 years back.
4.Subjects who were previously included or had participated in any other
clinical study within 30 days prior to the date of consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Proportion of adequate samples for evaluation out of total samples collected.
2.Concordance between HPV positive samples in Menstrual blood collected using M StripTM versus conventional method |
Day 1, Day 2 & Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Laboratory analysis and confirmation of the menstrual blood samples collected on the first three days of menstruation.
2. The prevalence of the different high risk HPV subtypes and the associated
cyto-morphological status of the cervix. |
Day 1, Day 2 & Day 3 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
16/12/2024 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The menstrual fluid collection device-M-StripTM intends to collect, store, and transport menstrual blood noninvasively for diagnostic, medical and research applications. According to the statistics in India, it is estimated that every year 1,23,907 women ages 15 years and older are diagnosed with cervical cancer and 77,348 die from the disease. Cervical cancer ranks as the 2nd most frequent cancer among women in India and the 2nd most frequent cancer among women between 15 and 44 years of age.1 Diseases like Human Papilloma Virus (HPV) can also spread through intimate skin-to-skin contact. Cervical cancer may be detected at early the stage stages by cervical cytology or HPV testing.2 There are studies demonstrating the possibility of using the menstrual blood as an HPV screening modality for cervical cancer.9 The menstrual fluid collection device-M-Strip can play a major role in overcoming the disadvantages of endometrial biopsy and helps in the diagnosis of HPV using the menstrual blood from the M-StripTM. |