A trial investigating the use of Veregen (EPIgallocatechin-3-gallate) in the treatment of Vulval Intraepithelial Neoplasia
| ISRCTN | ISRCTN98495886 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98495886 |
| Clinical Trials Information System (CTIS) | 2013-003107-19 |
| Protocol serial number | 15759 |
| Sponsor | University of Birmingham (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) |
- Submission date
- 17/12/2013
- Registration date
- 17/12/2013
- Last edited
- 11/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Miss Baljit Kaur
Scientific
Scientific
Cancer Research UK Clinical Trials Unit
School of Cancer Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
| b.kaur@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase II clinical trial investigating the use of EPIgallocatechin-3-gallate (Veregen) in the treatment of Vulval Intraepithelial Neoplasia |
| Study acronym | EPIVIN |
| Study objectives | The aim of this early phase trial is to determine if Veregen is a tolerable treatment with a level of activity that warrants further investigation in a definitive phase III trial. The trial will include women with histological diagnosis of VIN3 (usual type) and who have not received any prior treatment in the preceding 4 weeks. The primary objective objective of the trial is to determine whether topical application of epigallocatechin-3-gallate (Veregen) can induce histological resolution of VIN when assessed 32 weeks following the start of treatment. The secondary objectives of the trial are to supplement the primary outcome with analyses of objective response, patient safety, drug compliance and acceptability, need for further treatment, and quality of life. More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15759 |
| Ethics approval(s) | NRES Committee East Midlands - Derby, 20/12/2013, ref: 13/EM/0398 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Vulva |
| Intervention | 1. Experimental arm, Veregen 10% 2. Placebo Study Entry: Single Randomisation only |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Epigallocatechin-3-gallate (Veregen) |
| Primary outcome measure(s) |
Primary Outcome; Timepoint(s): 32 weeks |
| Key secondary outcome measure(s) |
Secondary outcome measures; Timepoint(s): 2, 4, 8, 16, 32 and 52 weeks |
| Completion date | 30/11/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 56 |
| Total final enrolment | 26 |
| Key inclusion criteria | 1. Female ≥ 18 years of age 2. Histological confirmation of 'usual' type vulval intraepithelial neoplasia (VIN3)* 3. At least one lesion that can be accurately measured (using the RECIST 1.1 criteria) in at least one dimension with longest diameter ≥ 20 mm 4. Using a reliable method of contraception (excluding condoms) 5. Written informed consent to participate in the trial * All histological material generated by this study will be assessed by Specialist Consultant in Gynaecological Pathology, 10% of biopsies will be independently reviewed by a second pathologist |
| Key exclusion criteria | 1. Suspected anogenital carcinoma or those considered by the attending clinician to be at high risk of developing invasive disease 2. Pregnant, breastfeeding or trying to conceive 3. Treated for VIN within the previous four weeks 4. Known allergy to Veregen or any of its components 5. Patients suffering from immunosuppressive disorder or taking immunosuppressives 6. Unable to comply with the protocol |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 10/05/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cancer Research UK Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/11/2020 | 18/11/2020 | Yes | No |
| Basic results | 28/05/2020 | No | No | ||
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 04/11/2021 | 11/11/2021 | No | Yes |
Editorial Notes
11/11/2021: Link to plain English results added.
18/11/2020: Publication reference added.
28/05/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
07/05/2020: The intention to publish date was changed from 30/11/2019 to 01/09/2020.
17/01/2018: The following changes were made:
1. The recruitment end date was changed from 01/01/2017 to 10/05/2017.
2. The overall trial end date was changed from 01/01/2017 to 30/11/2018.
3. Publication plan, intention to publish date and participant level data were added.
