Cervical Intraepithelial Neoplasia Grade 1TRICINNCT04400578
TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)
A study testing Trichloroacetic acid 85% (TCA) in people with Cervical Intraepithelial Neoplasia Grade 1 and Cervical Intraepithelial Neoplasia Grade 2, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
Trial summary
Trichloroacetic acid 85% =TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 1, Cervical Intraepithelial Neoplasia Grade 2
- What is being tested?
- Trichloroacetic acid 85% (TCA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteAustria
- Study dates
- 7 Feb 2020to 18 Jan 2022
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Histologically proven CIN 1/2
- adequate colposcopy (i.e. fully visible transformation zone and margins of any visible lesion)
- positive HPV test
- conducted negative pregnancy test
- women aged 18 to 50 years
- written informed consent
Who cannot join
- Exclusion criteria are a cytologically suspected CIN (Pap IIID, IV)
- inadequate colposcopy
- negative or missing biopsy
- cytology results indicating invasive disease (PAP V)
- if the cervical lesion recedes into the endocervical canal
- pregnancy
- any medical circumstance considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of gynaecology, Ordensklinikum Linz Ges.m.b.H, Barmherzige Schwestern
Linz, 4010
About this study
Trichloroacetic acid 85% =TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2. The device system is to be used only in accordance with the approved Investigational Plan on subjects, who have given written informed consent.
High remission and regression rates are expected after a single topical treatment with 85% TCA. After a single topical treatment with 85% TCA for CIN 1-2 (Expected 70% or higher; null hypothesis: not higher than 55%). Regression is defined as improvement from high grade lesion (CIN 2) at baseline to low grade lesion (CIN 1) after TCA treatment. Regression from CIN 1 normal squamous epithelium after the TCA treatment is equal to remission and will be counted as a remission in combined analysis. Remission is defined as complete histologic remission of CIN back to normal squamous epithelium after the TCA treatment, i.e., no cervical dysplasia is detectable by histology or cytology after the TCA treatment. Type-specific HPV Clearance is defined as disappearance of the HPV type detected at screening.
Read the detailed description
Visit and assessment Schedule:
Visit1 Screening:
- Informed Consent,
- Inclusion/Exclusion Criteria,
- Medical History,
- Gynecological Examination
- Cytology
- HPV Test
- Colposcopy
- Biopsy
- VAS (Visual analog scale)
- Pregnancy test
Visit 2 Treatment Day with TCA 85%:
- Colposcopy
- TCA Treatment
- VAS
- Pregnancy test
Visit 3, Control 1, Week 10-14:
- Cytology
- HPV Test
- Colposcopy
- Biopsy
- 4-quadrant biopsy
- ECC
- Adverse event monitoring If there is no sign of CIN during the colposcopic examination 10-14 weeks a 4-quadrant biopsy and a ECC are performed
Visit 4, Control 2, Week 22-26:
- Cytology
- HPV Test
- Colposcopy
- Biopsy
- 4-quadrant biopsy
- ECC
- Adverse event monitoring
- Pregnancy test If there is no sign of CIN during the colposcopic examination 22-26 weeks after the TCA treatment, a 4-quadrant biopsy and a ECC are performed.
Visit 5, EOS , Week 24-30:
- Results Discussion
- Being tested
- Trichloroacetic acid 85% (TCA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichloroacetic acid 85% (TCA)Device
Purpose and scope of Medical Device: Treatment and relief of a disease. Application to cervical intraepithelial neoplasia with a cotton swab.TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2.
| Study group | Role | What they receive |
|---|---|---|
| TRICIN | Experimental | If a patient is eligible
1. local anesthesia with Xylocain 10% with a pump spray for a period of 10 seconds- one time application
2. Procain 2%: local anesthesia with a swab for a period of 10 seconds- one time application
3. Trichloroacetic acid TCA 85% 1-2 ml with soaked swab for max. 2 minutes -one time application Receives: Device: Trichloroacetic acid 85% (TCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIN remission rate after treatment with TCA 85%
measured by histologic remission within 6 months
Measured: 6 months
Secondary outcomes (3)
CIN regression rate after treatment with TCA 85%
measured by histologic regression within 6 (improvement of at least one clinical CIN grade) months
Measured: 6 months
Pain scores
measured by Visual Analogue Scale of a single use of TCA 85% in patients with CIN 1/2
Measured: 6 months
Type specific human papillomavirus clearance rate after treatment with TCA 85%
human papillomavirus clearance rate after treatment with TCA 85% with CIN I/CIN // within 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start7 Feb 2020
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia Grade 1Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor
- Investigators
- Lukas Hefler, MD, Principal investigator, Krankenhaus Barmherzige Schwestern Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400578
- Sponsor's protocol ID
- EKS 48/19
- Acronym
- TRICIN
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)
- ClinicalTrials.gov ID
- NCT04400578
- Acronym / sponsor ID
- TRICIN / EKS 48/19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 22 May 2020 (actual)
- 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.
Trichloroacetic acid 85% =TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2. The device system is to be used only in accordance with the approved Investigational Plan on subjects, who have given written informed consent.
High remission and regression rates are expected after a single topical treatment with 85% TCA. After a single topical treatment with 85% TCA for CIN 1-2 (Expected 70% or higher; null hypothesis: not higher than 55%). Regression is defined as improvement from high grade lesion (CIN 2) at baseline to low grade lesion (CIN 1) after TCA treatment. Regression from CIN 1 normal squamous epithelium after the TCA treatment is equal to remission and will be counted as a remission in combined analysis. Remission is defined as complete histologic remission of CIN back to normal squamous epithelium after the TCA treatment, i.e., no cervical dysplasia is detectable by histology or cytology after the TCA treatment. Type-specific HPV Clearance is defined as disappearance of the HPV type detected at screening.
Detailed description
Visit and assessment Schedule:
Visit1 Screening:
- Informed Consent,
- Inclusion/Exclusion Criteria,
- Medical History,
- Gynecological Examination
- Cytology
- HPV Test
- Colposcopy
- Biopsy
- VAS (Visual analog scale)
- Pregnancy test
Visit 2 Treatment Day with TCA 85%:
- Colposcopy
- TCA Treatment
- VAS
- Pregnancy test
Visit 3, Control 1, Week 10-14:
- Cytology
- HPV Test
- Colposcopy
- Biopsy
- 4-quadrant biopsy
- ECC
- Adverse event monitoring If there is no sign of CIN during the colposcopic examination 10-14 weeks a 4-quadrant biopsy and a ECC are performed
Visit 4, Control 2, Week 22-26:
- Cytology
- HPV Test
- Colposcopy
- Biopsy
- 4-quadrant biopsy
- ECC
- Adverse event monitoring
- Pregnancy test If there is no sign of CIN during the colposcopic examination 22-26 weeks after the TCA treatment, a 4-quadrant biopsy and a ECC are performed.
Visit 5, EOS , Week 24-30:
- Results Discussion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRICIN | Experimental | Device: Trichloroacetic acid 85% (TCA)If a patient is eligible 1. local anesthesia with Xylocain 10% with a pump spray for a period of 10 seconds- one time application 2. Procain 2%: local anesthesia with a swab for a period of 10 seconds- one time application 3. Trichloroacetic acid TCA 85% 1-2 ml with soaked swab for max. 2 minutes -one time application |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Histologically proven CIN 1/2
- adequate colposcopy (i.e. fully visible transformation zone and margins of any visible lesion)
- positive HPV test
- conducted negative pregnancy test
- women aged 18 to 50 years
Key exclusion criteria (7 listed)
- Exclusion criteria are a cytologically suspected CIN (Pap IIID, IV)
- inadequate colposcopy
- negative or missing biopsy
- cytology results indicating invasive disease (PAP V)
- if the cervical lesion recedes into the endocervical canal
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 |
|---|---|---|
| Trichloroacetic acid 85% (TCA)Purpose and scope of Medical Device: Treatment and relief of a disease. Application to cervical intraepithelial neoplasia with a cotton swab.TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2. | Device | TRICIN |
Primary outcome
CIN remission rate after treatment with TCA 85%
Time frame: 6 months
measured by histologic remission within 6 months
3 secondary outcomes
CIN regression rate after treatment with TCA 85%
Time frame: 6 months
Pain scores
Time frame: 6 months
Type specific human papillomavirus clearance rate after treatment with TCA 85%
Time frame: 6 months
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 7 Apr 2022.
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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.
Lukas Hefler, MD principal investigator
Krankenhaus Barmherzige Schwestern Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trichloroacetic acid 85% (TCA) in people with Cervical Intraepithelial Neoplasia Grade 1 and Cervical Intraepithelial Neoplasia Grade 2, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. 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 7 Apr 2022. 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 Austria. 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?
CIN remission rate after treatment with TCA 85% (time frame: 6 months). 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 7 Apr 2022.