Cervical Intraepithelial NeoplasiaNCT01145781
Trial to Evaluate Single- and Double- Freeze Cryotherapy in the Prevention of Cervical Neoplasia
A study testing Cryotherapy in people with Cervical Intraepithelial Neoplasia, run by Tata Memorial Hospital at 1 site in India.
Trial summary
To evaluate whether single- and double-freeze cryotherapy techniques have similar efficacy in controlling different grades of cervical intraepithelial neoplasia (CIN), and have similar side effects and complications. Read more about this study
- Who is it for?
- Ages 25 to 64 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- Cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2010to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Women only
- No healthy volunteers
- Adult
Inclusion Criteria Apparently healthy women aged 25 to 64 yrs with following criteria will be eligible to participate in the study.
- Histological confirmation of ASCUS -H, CIN I, CIN II and CIN III lesions.
- The lesion confined to ecto cervix only.
- No obvious cervical and vaginal infection.
- Women in proliferative phase of menstrual cycle or post menopausal cases.
- Negative endo cervical curettage.
Exclusion criteria Women less than 25 and more than 64 years will not be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Intervention Trial to Evaluate Single- and Double- Freeze Cryotherapy in the Prevention of Cervical Neoplasia
To evaluate whether single- and double-freeze cryotherapy techniques have similar efficacy in controlling different grades of cervical intraepithelial neoplasia (CIN), and have similar side effects and complications.
Read the detailed description
Healthy women aged 25 to 64 yrs with histology confirmed ectocervical CIN lesions confined to ectocervix without extension to endocervix or vagina will be randomized to single- or double-freeze cryotherapy, as per the inclusion criteria will be invited to participate in the study.
They will be explained about the study. Informed consent will be obtained from each recruited woman. The cases selected with lesions that can be adequately covered with largest cryo probe (2.5 cm diameter) will be randomized between the following arms.
Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw. Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again.
The patients will be advised about excessive discharge per vagina for 4 weeks and mild abdominal cramps.
They will be advised to abstain from sexual intercourse for 6 weeks. They would be followed up after one month for clinical evaluation and at 12th month to determine the cure rates by Pap test, HPV Test and colposcopy with or without biopsy.
The reference investigations to determine cure rates at the end of 12 months would be Pap smear, HPV Testing by HC II and colposcopy with or with out biopsy which will be offered to all the participants and biopsy will be done on women with colposcopic abnormalities.
Randomized trial: Stratified by lesion. Randomisation and analysis will be stratified on the grades of CIN.
Randomisation process:
Each woman eligible for cryotherapy who presents for treatment, will be allocated a randomisation number.
This randomisation number is a 4 digit number: The first digit represent the CIN stage (1, 2 or 3), the 3 next digits are the sequential number of the patient (from 001 to 999). Each sequential number is randomly attributed to a treatment arm. The table containing this information will be kept by the principal investigator and is only known by the people involved in the treatment.
The arm the patient has been randomised to will not be known by the people performing the follow-up visit in order to avoid any reporting bias. As soon as the patient has been randomised to double- or single-freeze, the box corresponding to the sequential number line and the CIN column will be marked with 'X'. The randomisation protocol will be rigorously followed.
Women with biopsy proven ASCUS-H and CIN lesion, after obtaining an informed consent will be randomized between single and double freeze treatment cases. The first follow-up is after one month and the next at 12th month, where patient would be subjected to Pap test, HPV Test by Hybrid Capture II and colposcopy with or without biopsy.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Cryotherapy
- Keywords
- ectocervical CIN lesions
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw. Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again.
| Study group | Role | What they receive |
|---|---|---|
| Single-freeze cryotherapy | Active comparator | Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw. Receives: Procedure: Cryotherapy |
| Double-freeze cryotherapy | Active comparator | Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again. Receives: Procedure: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is the cure rate at the end of one year
The primary end point is the cure rate at the end of one year by comparing between two different techniques of cryotherapy i.e. single freeze and double freeze.
Measured: 1 year
Secondary outcomes (1)
The secondary end points are the rates and the types of side effects and complications
The secondary end points are the rates and the types of side effects and complications by comparing between two different techniques of cryotherapy i.e. single freeze and double freeze.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gauravi Ashish Mishra, Tata Memorial Hospital
- Investigators
- Gauravi A MIshra, MD, Principal investigator, Tata Memorial HospitalSharmila A Pimple, MD, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145781
- Sponsor's protocol ID
- 649
- Status last verified
- Apr 2018
- First submitted
- 16 Jun 2010
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Intervention Trial to Evaluate Single- and Double- Freeze Cryotherapy in the Prevention of Cervical Neoplasia
- ClinicalTrials.gov ID
- NCT01145781
- Acronym / sponsor ID
- 649
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- ectocervical CIN lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Jan 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether single- and double-freeze cryotherapy techniques have similar efficacy in controlling different grades of cervical intraepithelial neoplasia (CIN), and have similar side effects and complications.
Detailed description
Healthy women aged 25 to 64 yrs with histology confirmed ectocervical CIN lesions confined to ectocervix without extension to endocervix or vagina will be randomized to single- or double-freeze cryotherapy, as per the inclusion criteria will be invited to participate in the study.
They will be explained about the study. Informed consent will be obtained from each recruited woman. The cases selected with lesions that can be adequately covered with largest cryo probe (2.5 cm diameter) will be randomized between the following arms.
Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw. Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again.
The patients will be advised about excessive discharge per vagina for 4 weeks and mild abdominal cramps.
They will be advised to abstain from sexual intercourse for 6 weeks. They would be followed up after one month for clinical evaluation and at 12th month to determine the cure rates by Pap test, HPV Test and colposcopy with or without biopsy.
The reference investigations to determine cure rates at the end of 12 months would be Pap smear, HPV Testing by HC II and colposcopy with or with out biopsy which will be offered to all the participants and biopsy will be done on women with colposcopic abnormalities.
Randomized trial: Stratified by lesion. Randomisation and analysis will be stratified on the grades of CIN.
Randomisation process:
Each woman eligible for cryotherapy who presents for treatment, will be allocated a randomisation number.
This randomisation number is a 4 digit number: The first digit represent the CIN stage (1, 2 or 3), the 3 next digits are the sequential number of the patient (from 001 to 999). Each sequential number is randomly attributed to a treatment arm. The table containing this information will be kept by the principal investigator and is only known by the people involved in the treatment.
The arm the patient has been randomised to will not be known by the people performing the follow-up visit in order to avoid any reporting bias. As soon as the patient has been randomised to double- or single-freeze, the box corresponding to the sequential number line and the CIN column will be marked with 'X'. The randomisation protocol will be rigorously followed.
Women with biopsy proven ASCUS-H and CIN lesion, after obtaining an informed consent will be randomized between single and double freeze treatment cases. The first follow-up is after one month and the next at 12th month, where patient would be subjected to Pap test, HPV Test by Hybrid Capture II and colposcopy with or without biopsy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-freeze cryotherapy | Active comparator | Procedure: CryotherapyArm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw. |
| Double-freeze cryotherapy | Active comparator | Procedure: CryotherapyArm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyArm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw. Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again. | Procedure or surgery | Double-freeze cryotherapy, Single-freeze cryotherapy |
Primary outcome
The primary end point is the cure rate at the end of one year
Time frame: 1 year
The primary end point is the cure rate at the end of one year by comparing between two different techniques of cryotherapy i.e. single freeze and double freeze.
1 secondary outcome
The secondary end points are the rates and the types of side effects and complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gauravi A MIshra, MD principal investigator
Tata Memorial Hospital
Sharmila A Pimple, MD principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Cervical Intraepithelial Neoplasia, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point is the cure rate at the end of one year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.