Magnetic Resonance Imaging ExaminationNCT05487209
Clinical Value of the MRI Combined With SCC-Ag for the Diagnosis of HSIL (CIN 2/3)
An observational study of Magnetic Resonance Imaging Examination, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The study aimed to identify the clinical value of Magnetic Resonance Imaging examination (MRI)combined with serum squamous cells carcinoma antigen (SCC-Ag) in women with high-grade squamous intraepithelial lesion (cervical intraepithelial neoplasia grades 2-3 (CIN 2-3)). Read more about this study
- Who is it for?
- Ages 26 to 82 years, women only
- Conditions the study is for
- Magnetic Resonance Imaging Examination
- What is being tested?
- MRI,SCC-Ag
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 2022
- How long will I take part?
- 6 Months
- 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 26 to 82 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The present study conformed to the declaration of Helsinki and was approved by the Ethics Committee of Second Affiliated Hospital of Wenzhou Medical University. we prospectively collected the data of patients with HSIL(CIN2-3) from March 1 to September 31, 2021, all patients included in this study were followed up from admission to discharge. A total of 186 patients were eligible and signed written informed consent.
Who may be able to join
- No previous history of cervical lesions
- TCT and HPV test results suspected cervical lesions
- Further colposcopy showed HSIL or CIN 2-3
- All selected patients underwent MRI, serological tests for SCC-Ag levels, LEEP, or radical hysterectomy
Who cannot join
- Patients with receiving cold knife conization
- Patients with skin squamous cell carcinoma or previous history of cancer
- Pregnant women
- Patients with serious heart, liver, kidney, blood system and autoimmune diseases
Trial locations and contacts
1 site in 1 country.
China1 site
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, 325000
About this study
Official title: Clinical Value of the MRI Combined With SCC-Ag for the Diagnosis of High-grade Cervical Squamous Neoplasia (Cervical Intra-epithelial Neoplasia Grades 2 and 3 (CIN 2/3))
The study aimed to identify the clinical value of Magnetic Resonance Imaging examination (MRI)combined with serum squamous cells carcinoma antigen (SCC-Ag) in women with high-grade squamous intraepithelial lesion (cervical intraepithelial neoplasia grades 2-3 (CIN 2-3)).
Read the detailed description
186 female patients with the HSIL(CIN2-3) were included in this study and followed up from the time of admission. All patients underwent colposcopy examination, MRI, SCC-Ag, loop electrosurgical excision procedure (LEEP), extrafascial hysterectomy, or radical hysterectomy. Pathological findings of the patient's tissues were used as the final diagnostic criteria. On the one hand, we compared the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MRI+SCC-Ag, LEEP of the menopausal group, and non-menopausal group. On the other hand, evaluating the accuracy of MRI combined with SCC-Ag examination in diagnosing HSIL(CIN2-3) by receiver-operating characteristic curve (ROC)．
- Conditions
- Magnetic Resonance Imaging Examination
- Being tested
- MRI,SCC-Ag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI,SCC-AgDiagnostic test
Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen
| Study group | Role | What they receive |
|---|---|---|
| postmenopausal group | Not described Receives: Diagnostic Test: MRI,SCC-Ag | |
| non-menopausal group | Not described Receives: Diagnostic Test: MRI,SCC-Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of cases whose combined diagnosis of MRI and SCC Ag In postmenopausal women
In postmenopausal women, the number of cases whose combined diagnosis of MRI and SCC Ag consistent with the final pathological results
Measured: 20 days
the number of cases whose combined diagnosis of MRI and SCC Ag for the non-menopausal group.
In non-menopausal women, the number of cases whose combined diagnosis of MRI and SCC Ag consistent with the final pathological results
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Mar 2021
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Magnetic Resonance Imaging ExaminationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 186 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhao, Principal investigator, The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487209
- Sponsor's protocol ID
- SAHoWMU-CR2022-07-204
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Torre LA, Siegel RL, Ward EM, Jemal A. Global Cancer Incidence and Mortality Rates and Trends--An Update. Cancer Epidemiol Biomarkers Prev. 2016 Jan;25(1):16-27. doi: 10.1158/1055-9965.EPI-15-0578. Epub 2015 Dec 14.
PubMed 26667886Paavonen 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 19586656Fan A, Zhang L, Wang C, Wang Y, Han C, Xue F. Analysis of clinical factors correlated with the accuracy of colposcopically directed biopsy. Arch Gynecol Obstet. 2017 Nov;296(5):965-972. doi: 10.1007/s00404-017-4500-z. Epub 2017 Sep 9.
PubMed 28889237Sun X, Lei H, Xie X, Ruan G, An J, Sun P. Risk Factors for Residual Disease in Hysterectomy Specimens After Conization in Post-Menopausal Patients with Cervical Intraepithelial Neoplasia Grade 3. Int J Gen Med. 2020 Nov 10;13:1067-1074. doi: 10.2147/IJGM.S280576. eCollection 2020.
PubMed 33204141Chen P, Jiao L, Ren F, Wang DB. Clinical value of serum squamous cell carcinoma antigen levels in predicting chemosensitivity, lymph node metastasis, and prognosis in patients with cervical squamous cell carcinoma. BMC Cancer. 2020 May 14;20(1):423. doi: 10.1186/s12885-020-06934-x.
PubMed 32410650
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of the MRI Combined With SCC-Ag for the Diagnosis of High-grade Cervical Squamous Neoplasia (Cervical Intra-epithelial Neoplasia Grades 2 and 3 (CIN 2/3))
- ClinicalTrials.gov ID
- NCT05487209
- Acronym / sponsor ID
- SAHoWMU-CR2022-07-204
- Conditions
- Magnetic Resonance Imaging Examination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Aug 2022 (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.
The study aimed to identify the clinical value of Magnetic Resonance Imaging examination (MRI)combined with serum squamous cells carcinoma antigen (SCC-Ag) in women with high-grade squamous intraepithelial lesion (cervical intraepithelial neoplasia grades 2-3 (CIN 2-3)).
Detailed description
186 female patients with the HSIL(CIN2-3) were included in this study and followed up from the time of admission. All patients underwent colposcopy examination, MRI, SCC-Ag, loop electrosurgical excision procedure (LEEP), extrafascial hysterectomy, or radical hysterectomy. Pathological findings of the patient's tissues were used as the final diagnostic criteria. On the one hand, we compared the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MRI+SCC-Ag, LEEP of the menopausal group, and non-menopausal group. On the other hand, evaluating the accuracy of MRI combined with SCC-Ag examination in diagnosing HSIL(CIN2-3) by receiver-operating characteristic curve (ROC)．
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postmenopausal group | – | Diagnostic Test: MRI,SCC-Ag |
| non-menopausal group | – | Diagnostic Test: MRI,SCC-Ag |
Who may qualify
- Ages
- 26 to 82 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The present study conformed to the declaration of Helsinki and was approved by the Ethics Committee of Second Affiliated Hospital of Wenzhou Medical University. we prospectively collected the data of patients with HSIL(CIN2-3) from March 1 to September 31, 2021, all patients included in this study were followed up from admission to discharge. A total of 186 patients were eligible and signed written informed consent.
Key inclusion criteria (4 listed)
- No previous history of cervical lesions
- TCT and HPV test results suspected cervical lesions
- Further colposcopy showed HSIL or CIN 2-3
- All selected patients underwent MRI, serological tests for SCC-Ag levels, LEEP, or radical hysterectomy
Key exclusion criteria (4 listed)
- Patients with receiving cold knife conization
- Patients with skin squamous cell carcinoma or previous history of cancer
- Pregnant women
- Patients with serious heart, liver, kidney, blood system and autoimmune diseases
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 |
|---|---|---|
| MRI,SCC-AgMagnetic Resonance Imaging examination,serum squamous cells carcinoma antigen | Diagnostic test | non-menopausal group, postmenopausal group |
Primary outcome
The number of cases whose combined diagnosis of MRI and SCC Ag In postmenopausal women
Time frame: 20 days
In postmenopausal women, the number of cases whose combined diagnosis of MRI and SCC Ag consistent with the final pathological results
the number of cases whose combined diagnosis of MRI and SCC Ag for the non-menopausal group.
Time frame: 20 days
In non-menopausal women, the number of cases whose combined diagnosis of MRI and SCC Ag consistent with the final pathological results
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 6 Jul 2023.
- Background: PubMed 26667886Torre LA, Siegel RL, Ward EM, Jemal A. Global Cancer Incidence and Mortality Rates and Trends--An Update. Cancer Epidemiol Biomarkers Prev. 2016 Jan;25(1):16-27. doi: 10.1158/1055-9965.EPI-15-0578. Epub 2015 Dec 14.
- Background: 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.
- Background: PubMed 28889237Fan A, Zhang L, Wang C, Wang Y, Han C, Xue F. Analysis of clinical factors correlated with the accuracy of colposcopically directed biopsy. Arch Gynecol Obstet. 2017 Nov;296(5):965-972. doi: 10.1007/s00404-017-4500-z. Epub 2017 Sep 9.
- Background: PubMed 33204141Sun X, Lei H, Xie X, Ruan G, An J, Sun P. Risk Factors for Residual Disease in Hysterectomy Specimens After Conization in Post-Menopausal Patients with Cervical Intraepithelial Neoplasia Grade 3. Int J Gen Med. 2020 Nov 10;13:1067-1074. doi: 10.2147/IJGM.S280576. eCollection 2020.
- Background: PubMed 32410650Chen P, Jiao L, Ren F, Wang DB. Clinical value of serum squamous cell carcinoma antigen levels in predicting chemosensitivity, lymph node metastasis, and prognosis in patients with cervical squamous cell carcinoma. BMC Cancer. 2020 May 14;20(1):423. doi: 10.1186/s12885-020-06934-x.
- 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.
Zhao principal investigator
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
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 Magnetic Resonance Imaging Examination, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 4 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 6 Jul 2023. 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 China. 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 number of cases whose combined diagnosis of MRI and SCC Ag In postmenopausal women (time frame: 20 days). The study lists 2 primary outcomes in all. 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 NCT05487209, which also lists 5 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 6 Jul 2023.