Cervix, DysplasiaVENUSNCT04171505
Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.
An observational study of Cervix, Dysplasia and HPV Infection, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital between 2012-2018. The effectiveness of prophylactic vaccination against HPV in women treated for HPV-related disease will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Cervix, Dysplasia, HPV Infection, HPV Vaccine
- What is being tested?
- HPV vaccine
- Type of treatment
- Vaccines
- How many people
- 508 participants
- Where
- 1 siteSpain
- Study dates
- 4 Nov 2019to Dec 2020
- Phase
- Observational
- 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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital between 2012-2018
Who may be able to join
- Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically.
- Women who sign informed consent.
- Patients with negative results in the first post-surgery control.
- Patients who have received HPV vaccination and provide vaccination card.
Who cannot join
- Women who do not wish or cannot give their informed consent and / or do not comply with the requirements of the study.
- Patients treated by an indication other than HSIL/CIN.
- Patients under immunosuppression conditions.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
ANDREA CASAJUANA PEREZ, 0034 913 30 30 01, andreamercedes.casajuana@salud.madrid.org
About this study
Official title: Retrospective Cohort Study to Analyze Whether Prophylactic Vaccination Against HPV Can Reduce the Risk of Recurrence in Women Who Have Received an Excisional Therapy for HSIL / CIN2-3. Recurrence is Defined as the Detection of Infection by the Same HPV Genotype for at Least 6-12 Months (Persistent Infection), and / or Cytological Alteration and / or Cervical and / or Vaginal Histological Lesion of Any Grade (SIL / CIN / VaIN) in Patients With Negative Cotest in the First Post Control.
A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital between 2012-2018. The effectiveness of prophylactic vaccination against HPV in women treated for HPV-related disease will be evaluated. For this purpose, the percentage of cervical lesion recurrence among a group of treated and vaccinated women against HPV between the years 2015-2018 will be compared with a control group of treated and non-vaccinated women against HPV since 2012-2015.
It will be an essential requirement that the patient provide a vaccination card from their health center where there is proof of their immunization status and date of administration.
Read more
Inclusion criteria:
- Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically.
- Women who sign informed consent.
- Patients with negative results in the first post-surgery control.
- Patients who have received HPV vaccination and provide vaccination card.
Exclusion criteria:
- Women who do not wish or cannot give their informed consent and / or do not comply with the requirements of the study.
- Patients treated by an indication other than HSIL/CIN.
- Patients under immunosuppression conditions.
Read the detailed description
A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital (Madrid) between 2012-2018. The effectiveness of prophylactic vaccination against HPV in women treated for HPV-linked disease will be evaluated. For this purpose, the percentage of lesional recurrence among a group of treated and vaccinated women against HPV between the years 2015-2018 will be compared with a control group of treated and non-vaccinated women against HPV since 2012-2015. The data will be obtained through the review of clinical records.
Our protocol is explained above:
HPV detection method:
The detection of HPV is performed on a liquid basis by means of the CLARK PAPILOMAVIRUS HUMAN test that detects the presence of the HPV virus (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71.72, 73, 81, 82, 83, 84, 85 and 89). The test has a diagnostic sensitivity of 98.2% and a diagnostic specificity of 100% and analytical specificity: 100%. The analytical sensitivity of this test is 100% when the number of copies is 1,000 or 10,000 depending on the type of HPV. The Laboratory has carried out external quality control of the SEAP.
Pre-surgical evaluation:
Those patients with an abnormal cytological result and / or positive HPV tests were referred to the PTGI consultations of Clínico San Carlos Hospital for evaluation according to the Cervical Cancer Prevention Guidelines issued by the Spanish Association of Cervical Pathology and Colposcopy (AEPCC) in 2006 and 2014. These patients underwent colposcopy with biopsy if necessary +/- determination of HPV. Patients diagnosed with HSIL / CIN 2+ who met the inclusion criteria were submitted to cervical conization and subsequently enrolled in the study after signing the informed consent, approved by ethics commission.
We will take into account the date of administration of the first dose of vaccine. The types of vaccines administered can be: Bivalent vaccine (includes genotypes 16/18), Tetravalent (includeds genotypes 6, 11, 16 and 18) both funded in the region in different years, or not funded (Nonavalent vaccine; includes genotypes: 6, 11, 16, 18, 31, 33, 45, 52 and 58). To define the time of vaccination around the conization date, the administration of the first dose of vaccine will be taken into account.
Surgical treatment:
Excisional therapy was performed in the operating room on a scheduled basis under local analgesia and sedation. After infiltration with local anesthetic and vasoconstrictor in the 4 quadrants of the cervix, excisional therapy with diathermic loop is performed under colposcopy control, obtaining the piece in a single specimen. The piece is oriented with a long thread at 12:00 h, it is introduced in formaldehyde and send to pathological anatomy for deferred study. In all cases, immediate endocervical curettage post-treatment was performed.
Clinical follow-up:
The first revision is made 30 days after surgery where patient is informed of histological results and the date on first control post-treatment based on the diagnosis.
Following the protocol of the AEPCC, in case of non-involvement of margins and negative endocervical curettage, the patient comes after 6 months from the intervention to perform the first post-surgery control with co-test. In case of positive endocervical curettage or margin involvement, the first post-surgery control will be performed at 4 months with cotest + endocervical study and colposcopy. Persistent disease is defined as the presence of cytological alteration and / or HPV infection in the first post control performed at 4-6 months after excisional therapy. These patients are excluded from the study, since only those in which both tests are negative will be included.
Subsequently, a new co-test was performed at 12 months, 24 months and 36 months after the first post-surgery control. After 3 years of negative testing, the patient is returned to the current cervical cancer-screening program.
- Conditions
- Cervix, Dysplasia, HPV Infection, HPV Vaccine, Cervix Lesion
- Being tested
- HPV vaccine
- Medical subject headings
- Uterine Cervical Dysplasia, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccineDrug
. Patients diagnosed with HSIL / CIN 2+ who met the inclusion criteria were submitted to cervical conization and subsequently enrolled in the study after signing the informed consent, approved by ethics commission.
We will take into account the date of administration of the first dose of vaccine. The types of vaccines administered can be: Bivalent vaccine (includes genotypes 16/18), Tetravalent (includeds genotypes 6, 11, 16 and 18) both funded in the region in different years, or not funded (Nonavalent vaccine; includes genotypes: 6, 11, 16, 18, 31, 33, 45, 52 and 58). To define the time of vaccination around the conization date, the administration of the first dose of vaccine will be taken into account.
| Study group | Role | What they receive |
|---|---|---|
| vaccinated women | * Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically.
* Women who sign informed consent.
* Patients with negative results in the first post-surgery control.
* Patients who have received HPV vaccination and provide vaccination card. Receives: Drug: HPV vaccine | |
| non vaccinated woman | * Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically. * Women who sign informed consent. * Patients with negative results in the first post-surgery control. * Patients who have NOT received HPV vaccination and provide vaccination card. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
defined as the existence of persistent HPV infection and / or presence of cytological abnormality and / or presence of SIL / CIN / VaIN of any grade.
Measured: 2 years
Secondary outcomes (1)
Age, type of virus, degree of injury, variables related to demographic and histological data of the patient, date of 1st dose of vaccine.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start4 Nov 2019
- Primary completion4 Nov 2019
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervix, DysplasiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, ANDREA CASAJUANA, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171505
- Sponsor's protocol ID
- ISM-190623
- Acronym
- VENUS
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang WD, Choi HS, Kim SM. Is vaccination with quadrivalent HPV vaccine after loop electrosurgical excision procedure effective in preventing recurrence in patients with high-grade cervical intraepithelial neoplasia (CIN2-3)? Gynecol Oncol. 2013 Aug;130(2):264-8. doi: 10.1016/j.ygyno.2013.04.050. Epub 2013 Apr 26.
PubMed 23623831FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741.
PubMed 17494925Ghelardi A, Parazzini F, Martella F, Pieralli A, Bay P, Tonetti A, Svelato A, Bertacca G, Lombardi S, Joura EA. SPERANZA project: HPV vaccination after treatment for CIN2. Gynecol Oncol. 2018 Nov;151(2):229-234. doi: 10.1016/j.ygyno.2018.08.033. Epub 2018 Sep 6. No abstract available.
PubMed 30197061Pieralli A, Bianchi C, Auzzi N, Fallani MG, Bussani C, Fambrini M, Cariti G, Scarselli G, Petraglia F, Ghelardi A. Indication of prophylactic vaccines as a tool for secondary prevention in HPV-linked disease. Arch Gynecol Obstet. 2018 Dec;298(6):1205-1210. doi: 10.1007/s00404-018-4926-y. Epub 2018 Oct 10.
PubMed 30306310Velentzis LS, Brotherton JML, Canfell K. Recurrent disease after treatment for cervical pre-cancer: determining whether prophylactic HPV vaccination could play a role in prevention of secondary lesions. Climacteric. 2019 Dec;22(6):596-602. doi: 10.1080/13697137.2019.1600500. Epub 2019 Apr 29.
PubMed 31030590Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Hedrick J, Jaisamrarn U, Limson G, Garland S, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Jenkins D, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009 Jul 25;374(9686):301-14. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6.
PubMed 19586656
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study to Analyze Whether Prophylactic Vaccination Against HPV Can Reduce the Risk of Recurrence in Women Who Have Received an Excisional Therapy for HSIL / CIN2-3. Recurrence is Defined as the Detection of Infection by the Same HPV Genotype for at Least 6-12 Months (Persistent Infection), and / or Cytological Alteration and / or Cervical and / or Vaginal Histological Lesion of Any Grade (SIL / CIN / VaIN) in Patients With Negative Cotest in the First Post Control.
- ClinicalTrials.gov ID
- NCT04171505
- Acronym / sponsor ID
- VENUS / ISM-190623
- Conditions
- Cervix, Dysplasia, HPV Infection, HPV Vaccine, Cervix Lesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 508 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 21 Nov 2019 (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.
A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital between 2012-2018. The effectiveness of prophylactic vaccination against HPV in women treated for HPV-related disease will be evaluated. For this purpose, the percentage of cervical lesion recurrence among a group of treated and vaccinated women against HPV between the years 2015-2018 will be compared with a control group of treated and non-vaccinated women against HPV since 2012-2015.
It will be an essential requirement that the patient provide a vaccination card from their health center where there is proof of their immunization status and date of administration.
Inclusion criteria:
- Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically.
- Women who sign informed consent.
- Patients with negative results in the first post-surgery control.
- Patients who have received HPV vaccination and provide vaccination card.
Exclusion criteria:
- Women who do not wish or cannot give their informed consent and / or do not comply with the requirements of the study.
- Patients treated by an indication other than HSIL/CIN.
- Patients under immunosuppression conditions.
Detailed description
A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital (Madrid) between 2012-2018. The effectiveness of prophylactic vaccination against HPV in women treated for HPV-linked disease will be evaluated. For this purpose, the percentage of lesional recurrence among a group of treated and vaccinated women against HPV between the years 2015-2018 will be compared with a control group of treated and non-vaccinated women against HPV since 2012-2015. The data will be obtained through the review of clinical records.
Our protocol is explained above:
HPV detection method:
The detection of HPV is performed on a liquid basis by means of the CLARK PAPILOMAVIRUS HUMAN test that detects the presence of the HPV virus (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71.72, 73, 81, 82, 83, 84, 85 and 89). The test has a diagnostic sensitivity of 98.2% and a diagnostic specificity of 100% and analytical specificity: 100%. The analytical sensitivity of this test is 100% when the number of copies is 1,000 or 10,000 depending on the type of HPV. The Laboratory has carried out external quality control of the SEAP.
Pre-surgical evaluation:
Those patients with an abnormal cytological result and / or positive HPV tests were referred to the PTGI consultations of Clínico San Carlos Hospital for evaluation according to the Cervical Cancer Prevention Guidelines issued by the Spanish Association of Cervical Pathology and Colposcopy (AEPCC) in 2006 and 2014. These patients underwent colposcopy with biopsy if necessary +/- determination of HPV. Patients diagnosed with HSIL / CIN 2+ who met the inclusion criteria were submitted to cervical conization and subsequently enrolled in the study after signing the informed consent, approved by ethics commission.
We will take into account the date of administration of the first dose of vaccine. The types of vaccines administered can be: Bivalent vaccine (includes genotypes 16/18), Tetravalent (includeds genotypes 6, 11, 16 and 18) both funded in the region in different years, or not funded (Nonavalent vaccine; includes genotypes: 6, 11, 16, 18, 31, 33, 45, 52 and 58). To define the time of vaccination around the conization date, the administration of the first dose of vaccine will be taken into account.
Surgical treatment:
Excisional therapy was performed in the operating room on a scheduled basis under local analgesia and sedation. After infiltration with local anesthetic and vasoconstrictor in the 4 quadrants of the cervix, excisional therapy with diathermic loop is performed under colposcopy control, obtaining the piece in a single specimen. The piece is oriented with a long thread at 12:00 h, it is introduced in formaldehyde and send to pathological anatomy for deferred study. In all cases, immediate endocervical curettage post-treatment was performed.
Clinical follow-up:
The first revision is made 30 days after surgery where patient is informed of histological results and the date on first control post-treatment based on the diagnosis.
Following the protocol of the AEPCC, in case of non-involvement of margins and negative endocervical curettage, the patient comes after 6 months from the intervention to perform the first post-surgery control with co-test. In case of positive endocervical curettage or margin involvement, the first post-surgery control will be performed at 4 months with cotest + endocervical study and colposcopy. Persistent disease is defined as the presence of cytological alteration and / or HPV infection in the first post control performed at 4-6 months after excisional therapy. These patients are excluded from the study, since only those in which both tests are negative will be included.
Subsequently, a new co-test was performed at 12 months, 24 months and 36 months after the first post-surgery control. After 3 years of negative testing, the patient is returned to the current cervical cancer-screening program.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaccinated women | – | Drug: HPV vaccine* Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically. * Women who sign informed consent. * Patients with negative results in the first post-surgery control. * Patients who have received HPV vaccination and provide vaccination card. |
| non vaccinated woman | – | –* Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically. * Women who sign informed consent. * Patients with negative results in the first post-surgery control. * Patients who have NOT received HPV vaccination and provide vaccination card. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital between 2012-2018
Key inclusion criteria (4 listed)
- Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically.
- Women who sign informed consent.
- Patients with negative results in the first post-surgery control.
- Patients who have received HPV vaccination and provide vaccination card.
Key exclusion criteria (3 listed)
- Women who do not wish or cannot give their informed consent and / or do not comply with the requirements of the study.
- Patients treated by an indication other than HSIL/CIN.
- Patients under immunosuppression conditions.
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 |
|---|---|---|
| HPV vaccine. Patients diagnosed with HSIL / CIN 2+ who met the inclusion criteria were submitted to cervical conization and subsequently enrolled in the study after signing the informed consent, approved by ethics commission. We will take into account the date of administration of the first dose of vaccine. The types of vaccines administered can be: Bivalent vaccine (includes genotypes 16/18), Tetravalent (includeds genotypes 6, 11, 16 and 18) both funded in the region in different years, or not funded (Nonavalent vaccine; includes genotypes: 6, 11, 16, 18, 31, 33, 45, 52 and 58). To define the time of vaccination around the conization date, the administration of the first dose of vaccine will be taken into account. | Drug | vaccinated women |
Primary outcome
Recurrence
Time frame: 2 years
defined as the existence of persistent HPV infection and / or presence of cytological abnormality and / or presence of SIL / CIN / VaIN of any grade.
1 secondary outcome
Age, type of virus, degree of injury, variables related to demographic and histological data of the patient, date of 1st dose of vaccine.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Results publication: PubMed 23623831Kang WD, Choi HS, Kim SM. Is vaccination with quadrivalent HPV vaccine after loop electrosurgical excision procedure effective in preventing recurrence in patients with high-grade cervical intraepithelial neoplasia (CIN2-3)? Gynecol Oncol. 2013 Aug;130(2):264-8. doi: 10.1016/j.ygyno.2013.04.050. Epub 2013 Apr 26.
- Results publication: PubMed 17494925FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741.
- Results publication: PubMed 30197061Ghelardi A, Parazzini F, Martella F, Pieralli A, Bay P, Tonetti A, Svelato A, Bertacca G, Lombardi S, Joura EA. SPERANZA project: HPV vaccination after treatment for CIN2. Gynecol Oncol. 2018 Nov;151(2):229-234. doi: 10.1016/j.ygyno.2018.08.033. Epub 2018 Sep 6. No abstract available.
- Results publication: PubMed 30306310Pieralli A, Bianchi C, Auzzi N, Fallani MG, Bussani C, Fambrini M, Cariti G, Scarselli G, Petraglia F, Ghelardi A. Indication of prophylactic vaccines as a tool for secondary prevention in HPV-linked disease. Arch Gynecol Obstet. 2018 Dec;298(6):1205-1210. doi: 10.1007/s00404-018-4926-y. Epub 2018 Oct 10.
- Results publication: PubMed 31030590Velentzis LS, Brotherton JML, Canfell K. Recurrent disease after treatment for cervical pre-cancer: determining whether prophylactic HPV vaccination could play a role in prevention of secondary lesions. Climacteric. 2019 Dec;22(6):596-602. doi: 10.1080/13697137.2019.1600500. Epub 2019 Apr 29.
- Results publication: PubMed 19586656Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Hedrick J, Jaisamrarn U, Limson G, Garland S, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Jenkins D, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009 Jul 25;374(9686):301-14. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervix, Dysplasia and HPV Infection, run by Hospital San Carlos, Madrid at 1 site in Spain.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Nov 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANDREA CASAJUANA PÉREZ (0034 913 30 30 01, andreamercedes.casajuana@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 2 years). 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 NCT04171505, which also lists 6 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 21 Nov 2019.