| CTRI Number |
CTRI/2021/03/032424 [Registered on: 30/03/2021] Trial Registered Prospectively |
| Last Modified On: |
25/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF TWO TREATMENT MODALITIES OF EARLY CERVICAL CANCER (CIN 2&3)LEEP V/S THERMAL ABLATION |
|
Scientific Title of Study
|
THERMAL ABLATION VERSUS LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP)IN TREATMENT OF CERVICAL INTRAEPITHELIAL NEOPLASIA CIN 2&3 :AN EXPLORATORY TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MAHIMA MAHAMOOD M M |
| Designation |
JUNIOR RESIDENT ACADEMIC |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE ,RISHIKESH |
| Address |
DEPARTMENT OF OBSTRETICS AND GYNECOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCE ,RISHIKESH
DEHRADUN
UTTARAKHAND
PIN:249203
DEPARTMENT OF OBSTRETICS AND GYNECOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCE ,RISHIKESH
DEHRADUN
UTTARAKHAND
PIN:249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8532822577 |
| Fax |
|
| Email |
Mahimamahamood94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANUPAMA BAHADUR |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE ,RISHIKESH |
| Address |
DEPARTMENT OF OBSTRETICS AND GYNECOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCE ,RISHIKESH
DEHRADUN
UTTARAKHAND
PIN:249203
DEPARTMENT OF OBSTRETICS AND GYNECOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCE ,RISHIKESH
DEHRADUN
UTTARAKHAND
PIN:249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9810326959 |
| Fax |
|
| Email |
anupama.bahadur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAHIMA MAHAMOOD M M |
| Designation |
JUNIOR RESIDENT ACADEMIC |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE ,RISHIKESH |
| Address |
DEPARTMENT OF OBSTRETICS AND GYNECOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCE ,RISHIKESH
DEHRADUN
UTTARAKHAND
PIN:249203
DEPARTMENT OF OBSTRETICS AND GYNECOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCE ,RISHIKESH
DEHRADUN
UTTARAKHAND
PIN:249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8532822577 |
| Fax |
|
| Email |
Mahimamahamood94@gmail.com |
|
|
Source of Monetary or Material Support
|
| AII INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH |
|
|
Primary Sponsor
|
| Name |
AII INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH |
| Address |
AII INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH,DEHRADUN
UTTARAKHAND
|
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MAHIMA MAHAMOOD |
AIIMS RISHIKESH |
JUNIOR RESIDENT ACADEMIC
DEPARTMENT OF OBSTRETICS AND GYNECOLOGY
AIIMS RISHIKESH
DEHRADUN
UTTARAKHAND
PIN:673305
Dehradun
UTTARANCHAL |
8532822577
Mahimamahamood94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS RISHIKESH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D069||Carcinoma in situ of cervix, unspecified, (2) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
THERMAL ABLATION VERSUS LOOP
ELECTROSURGICAL EXCISION PROCEDURE
(LEEP) IN TREATMENT OF CERVICAL
INTRA- EPITHELIAL NEOPLASIA CIN 2 & 3:
A Time bound exploratory Trial
|
Patients will be recruited from Gynecology OPD AIIMS Rishikesh and outreach camps. All women aged 25-55 years will undergo complete history and examination, including per speculum examination. Simultaneously all women will undergo routine PAP smear testing/ visual inspection with acetic acid (VIA) and visual inspection with Lugol’s iodine (VILI) after due consent. Once patients are found fit for study with either abnormal pap smear results or screen positive in screen and treat approach, informed written consent will be taken from the patients. All patients will be taken up for colposcopy and then will be placed into either of the 2 treatment modalities (LEEP and thermal coagulation) by randomization. |
| Intervention |
TIME BOUND EXPLORATORY TRIAL |
Patients will be recruited from Gynecology OPD AIIMS Rishikesh and outreach camps. All women aged 25-55 years will undergo complete history and examination, including per speculum examination. Simultaneously all women will undergo routine PAP smear testing/ visual inspection with acetic acid (VIA) and visual inspection with Lugol’s iodine (VILI) after due consent. Once patients are found fit for study with either abnormal pap smear results or screen positive in screen and treat approach, informed written consent will be taken from the patients. All patients will be taken up for colposcopy and then will be placed into either of the 2 treatment modalities (LEEP and thermal coagulation) by randomization.
Time of study 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Women with age group 25-55 years
2. Women who have histologically confirmed CIN 2 & 3 lesions
3. Women who have been screened positive (positive with high risk HPV or visual inspection with acetic acid / VIA) in a screen-and-treat strategy.
4. Women with abnormal cytology (High-grade Squamous Intra-epithelial Lesion / HSIL)
5. Transformation zone (TZ) is fully visible, whole lesion is visible and it does not extend into the endocervix, or the lesion is type 1 TZ; or the lesion is type 2 TZ where the probe tip will achieve complete ablation of the SCJ epithelium, i.e., where it can reach the upper limit of the TZ.
|
|
| ExclusionCriteria |
| Details |
• Women with obvious growth on cervix.
• Women with high index of suspicion of invasive cancer cervix .
• Women with lesion occupying more than two quadrants of cervix or with vaginal and/or endocervical extension.
• Lesion is type 3 TZ (TZ is not fully visible because it is endocervical); or lesion is type 2 TZ where the SCJ is out of reach of the probe tip.
• Pregnant women
• Women with severe debilitating disease
• Women with history of pelvic irradiation
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate acceptability effectiveness and side effects in women of CIN 2 3 lesions treated with Thermal coagulation and LEEP.
2. Comparing the results in the two treated groups, one by loop electrosurgical excision procedure (LEEP) and one by thermal ablation, in terms of acceptability, efficacy, complications, disease recurrence persistence and on follow up of 6 months.
|
1,3,6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To examine and compare the effect of Thermal ablation and LEEP on overall sexual satisfaction and other specific aspects of sexual function in women in CIN 2 & 3. |
6months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/03/2021 |
| 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="2"
Months="0"
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)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Mahimamahamood94@gmail.com].
- For how long will this data be available start date provided 18-03-2021 and end date provided 18-10-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
PRIMARY OBJECTIVE 1. To evaluate acceptability, effectiveness and side effects in women of CIN 2 & 3 lesions treated with Thermal coagulation and LEEP. 2. Comparing the results in the two treated groups, one by loop electrosurgical excision procedure (LEEP) and one by thermal ablation, in terms of acceptability, efficacy, complications, disease recurrence/ persistence and on follow up of 6 months.
SECONDARY OBJECTIVES 1.To examine and compare the effect of Thermal ablation and LEEP on overall sexual satisfaction and other specific aspects of sexual function in women in CIN 2 & 3.
|