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Cervix; Intraepithelial NeoplasiaNCT04911075

Depth of Necrosis in Normal Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application

A study testing 85% TCA Solution in people with Cervix; Intraepithelial Neoplasia, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Early detection and treatment of precancerous lesions are the pillars of cervical cancer prevention. Cervical Intraepithelial Neoplasia (CIN) is a precancerous lesion that histologically can be found in one of three stages of development; CIN-I (low grade), CIN-II, or CIN-III (collectively called high grade)… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Cervix; Intraepithelial Neoplasia
What is being tested?
85% TCA Solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIndonesia
Study dates
15 Apr 2021to 25 Oct 2021
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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Normal cervix without significant changes and must be tested negative for Visual Inspection Acetic-Acid (VIA) test (no acetowhite lesions are found)
  • Participants are willing to participate voluntarily in this research by signing a consent form.

Who cannot join

  • Patients who finally have undergone sub-total or supra-vaginal hysterectomy.
  • Any abnormalities found in postoperative cervical histopathology results.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • dr. Cipto Mangunkusumo National Central General Hospital

    Jakarta, 10430

Other trials in Indonesia

About this study

Early detection and treatment of precancerous lesions are the pillars of cervical cancer prevention. Cervical Intraepithelial Neoplasia (CIN) is a precancerous lesion that histologically can be found in one of three stages of development; CIN-I (low grade), CIN-II, or CIN-III (collectively called high grade), depending on the proportion of the depth of the lesion to the thickness of the cervical epithelium. The higher the degree of CIN, the deeper the pre-cancerous lesions are found in the epithelial lining of the cervix. Therefore, from the point of view of precancerous lesions treatment, its effectiveness will be determined by the ability to eradicate all high-grade lesions. In other words, it has an effect that can reach depths beyond the depth of the high grade lesion.

According to a study in the US (1982), as many as 99.7% of CIN-III cases had a lesion depth of less than 4.8 millimeter. Furthermore, a Netherlands study (1990) stated that as many as 99.7% of CIN-III cases had a maximum lesion depth of 3.6 millimeters. While in subjects from developing countries, study from Peru (2018) showed that 93.5% of CIN-III cases have a lesion depth of less than 5 millimeters. Based on the results of these studies, a treatment for CIN can only be said to be effective if it can create a therapeutic effect which can reach depths of 4-5 millimeters in cervix epithelial.

Trichloroacetic acid (TCA) is an acetic acid analogue, which has long been known as a chemical peel and also frequently used to treat genital ward and precancerous skin lesions. The effect of TCA therapy is the destruction of the epithelium forming epithelial necrosis, followed by re-epithelialization of the supporting tissue and stimulation of collagen synthesis within approximately in 24 hours. There are no studies regarding the depth of cervical necrosis that can be achieved by application of this solution to the cervix epithelial.

Read the detailed description

Primary Objectives:

The purpose of this study is to determine the depth of epithelial necrosis in cervical tissue specimen after 85 percent TCA application on clinically normal cervix.

Procedure:

Patients will receive a single administration of 1-2 milliliter of 85 percent TCA in 24 hours before elective total hysterectomy surgery on indication other than cervical pathology. The 85 percent TCA will be applied topically onto the ectocervix and the endocervix canal with a cotton swab for 1-2 minutes. After surgery, cervical specimen will be fixated in formalin and sent for histopathologic examination.

Being tested
85% TCA Solution
Keywords
Trichloroacetic Acid (TCA), Depth of Necrosis, Cervix Intraepithelial Neoplasia
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.

  • 85% TCA SolutionDrug

    Also called CCl₃COOH

    • TCA is an acetic acid analogue solution (CCl3COOH) which is formed from the reaction of acetic acid (CH3COOH) with chlorine (3Cl2).
    • High concentrations (85 percent) of this solution can penetrate deeply into the epidermis-dermis layer and cause cells necrosis.
    • This solution (1-2 milliliter) will be applied to participants cervical tissue (ectocervix and endocervix) using cotton swab for 1-3 minutes.
Study groups in NCT04911075
Study groupRoleWhat they receive
85% TCA GroupExperimental* Participants are subject who will undergo an elective total hysterectomy procedure for indications of gynecological organ abnormalities, whether benign, pre-cancerous, or malignant other than cervical pathology. * The 85 percent TCA solution will be applied to participants cervical tissue 24 hours before surgery.
Receives: Drug: 85% TCA Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depth of Cervical Epithelial Ablation

    Based on damage to the cervical epithelium, both squamous (ectocervix), transformation zone, and columnar (endocervix) epithelium. Destruction of base membrane and stromal tissue will also be evaluated. Microscopic evaluation using a micrometer on a 10 times magnification eyepiece. The deepest ablative destruction in epithelial, base membrane, and stromal tissue will be recorded and stated in millimetres.

    Measured: 30 days

Secondary outcomes (1)

  1. Pain Scores

    Measured immediately after application of the 85 percent TCA solution with Visual Analogue Scale (VAS) score. Highest score means worse ouctcome. Minimum score is 0 (No Pain) and maximum score is 10 (worst pain).

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2021
  2. Study start15 Apr 2021
  3. Primary completion25 Oct 2021
  4. Study completion25 Oct 2021

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04911075
Sponsor's protocol ID
21020134
Status last verified
Nov 2021
First submitted
24 May 2021
Last updated
2 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie results in a publication

Publications

  • Boonstra H, Aalders JG, Koudstaal J, Oosterhuis JW, Janssens J. Minimum extension and appropriate topographic position of tissue destruction for treatment of cervical intraepithelial neoplasia. Obstet Gynecol. 1990 Feb;75(2):227-31.

    PubMed 2300349

  • Abdul-Karim FW, Fu YS, Reagan JW, Wentz WB. Morphometric study of intraepithelial neoplasia of the uterine cervix. Obstet Gynecol. 1982 Aug;60(2):210-4.

    PubMed 7155483

  • Taxa L, Jeronimo J, Alonzo TA, Gage J, Castle PE, Cremer ML, Felix JC. Depth of Cervical Intraepithelial Neoplasia Grade 3 in Peruvian Women: Implications for Therapeutic Depth of Necrosis. J Low Genit Tract Dis. 2018 Jan;22(1):27-30. doi: 10.1097/LGT.0000000000000355.

    PubMed 29271853

  • Brodland DG, Cullimore KC, Roenigk RK, Gibson LE. Depths of chemexfoliation induced by various concentrations and application techniques of trichloroacetic acid in a porcine model. J Dermatol Surg Oncol. 1989 Sep;15(9):967-71. doi: 10.1111/j.1524-4725.1989.tb03183.x.

    PubMed 2778185

  • Mariategui J, Santos C, Taxa L, Jeronimo J, Castle PE. Comparison of depth of necrosis achieved by CO2- and N2O-cryotherapy. Int J Gynaecol Obstet. 2008 Jan;100(1):24-6. doi: 10.1016/j.ijgo.2007.07.009. Epub 2007 Sep 25.

    PubMed 17897647

  • Adepiti AC, Ajenifuja OK, Fadahunsi OO, Osasan SA, Pelemo OE, Loto MO. Comparison of the depth of tissue necrosis between double-freeze and single-freeze nitrous oxide-based cryotherapy. Niger Med J. 2016 Jan-Feb;57(1):1-4. doi: 10.4103/0300-1652.180561.

    PubMed 27185971

  • Geisler S, Speiser S, Speiser L, Heinze G, Rosenthal A, Speiser P. Short-Term Efficacy of Trichloroacetic Acid in the Treatment of Cervical Intraepithelial Neoplasia. Obstet Gynecol. 2016 Feb;127(2):353-9. doi: 10.1097/AOG.0000000000001244.

    PubMed 26942365

  • Walker DC, Brown BH, Blackett AD, Tidy J, Smallwood RH. A study of the morphological parameters of cervical squamous epithelium. Physiol Meas. 2003 Feb;24(1):121-35. doi: 10.1088/0967-3334/24/1/309.

    PubMed 12636191

Questions about this trial

What is this clinical trial studying?

A study testing 85% TCA Solution in people with Cervix; Intraepithelial Neoplasia, run by Universitas Indonesia at 1 site in Indonesia.

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 2 inclusion and 2 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 2 Dec 2021. 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 Indonesia. 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?

Depth of Cervical Epithelial Ablation (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04911075, which also lists 8 linked publications.

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 2 Dec 2021.

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