VaginitisNCT04984460
Morphological Detection of Liquid-based Thin-layer Film-making Fungi for Fungal Vaginitis in Multiple Hospitals
An observational study of Vaginitis, run by Affiliated Hospital of Nantong University at 10 sites in China.
Trial summary
The purpose of this study is to compare the results of different detection methods for non-gestational fungal vaginitis (VVC), and to evaluate the significance of different fungal states in the results for diagnosis and treatment. Read more about this study
- Who is it for?
- Ages 14 to 70 years, women only
- Conditions the study is for
- Vaginitis
- What is being tested?
- Fluorescence morphological detection of liquid-based thin-layer film-making fungi
- How many people
- 1,000 participants
- Where
- 10 sitesChina
- Study dates
- 9 Jul 2021to 1 Apr 2023
- How long will I take part?
- 10 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 14 to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female patients with suspected fungal vaginitis.
Who may be able to join
- 1. Samples from outpatient or inpatient clinics to be tested for fungal vaginitis.
- 2. A sample of one or more of the following characteristics. 2.1 Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased.
- 2.2 Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd.
- 3. The samples are vaginal secretions from the female body. Each sample should be the amount on one swab.
- 4. The sample is not in menstrual period.
- 5. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days.
Who cannot join
- 1. Cases with incomplete specimen collection;
- 2. Mixed vaginitis cases;
- 3. Abscission cases with incomplete follow-up.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
The First Affiliated Hospital of Ustc
Hefei, Anhui, 230031
Jiujiang Maternal and Child Health Hospital
Jiujiang, Jiangxi
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006
The Second Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226006
Affiliated Nantong Hospital Of Shanghai University
Nantong, Jiangsu
Nantong Maternal and Child Health Hospital
Nantong, Jiangsu
Children's Hospital of Fudan University Qidong Branch
Qidong, Jiangsu
Changning District Maternal and Child Health Care Hospital
Shanghai, Shanghai Municipality, 200051
Zhongshan City People's Hospital
Zhongshan, Guangdong
About this study
Official title: A Multicenter Clinical Study on Liquid-based Morphological Detection of Fungi
The purpose of this study is to compare the results of different detection methods for non-gestational fungal vaginitis (VVC), and to evaluate the significance of different fungal states in the results for diagnosis and treatment.
Read the detailed description
The study was divided into two phases: in the first phase, the vaginal secretions of 1000 enrolled patients with fungal vaginitis were detected with 3/4 different methods, and the sensitivity, specificity and consistency of these methods were compared; In the second stage, 1000 patients from the first stage were selected to meet the follow-up stage and divided into two groups. The test of Follow-up fungal culture and fluorescence morphological detection of liquid-based thin-layer film-making fungi were performed periodically. At last, the applicant will analyze the data, write the paper and publish the article.
- Conditions
- Vaginitis
- Being tested
- Fluorescence morphological detection of liquid-based thin-layer film-making fungi
- Keywords
- Fluorescence morphological, liquid-based thin-layer film-making, Fungal vaginitis
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence morphological detection of liquid-based thin-layer film-making fungiDiagnostic test
Samples from outpatient or inpatient clinics to be tested for fungal vaginitis. A sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased.
Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd.
Samples are human vaginal secretions. Each sample should be the amount on one swab.
The sample is not in menstrual period. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days.
| Study group | Role | What they receive |
|---|---|---|
| life-style counseling | A sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased.
Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd. Receives: Diagnostic Test: Fluorescence morphological detection of liquid-based thin-layer film-making fungi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the positive detection rate of 3/4 different detection methods in the first phase.
The positive coincidence rate (sensitivity), negative coincidence rate (specificity) and total coincidence rate (consistency) was compared, according to the P<0.05 was used to determine whether it was statistically significant.
Measured: From Aug. 1st to Dec. 31st, 2021
Calculating the proportion of the number of fungi in three different states in the map results of three/four detection methods.
Counting The number and proportion of mycelia, spores and blastospores, especially the percentage of cases of single spore (+) in all cases of fungus (+).
Measured: From Aug. 1st, 2021 to Jan. 31st, 2022
Counting the positive numbers of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests and fungal culture in the Stage 2_follow-up stage.
the positive coincidence rate (sensitivity), negative coincidence rate (specificity) of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests
Measured: From Mar. 1, 2022 to Dec. 31st, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start9 Jul 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuquan Zhang, Affiliated Hospital of Nantong University
- Investigators
- Yuquan Zhang, Doctor, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984460
- Sponsor's protocol ID
- AHNantongU_YEZH_NTFS_V1.0
- Status last verified
- Jul 2021
- First submitted
- 22 Jul 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planning sharing at present.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on Liquid-based Morphological Detection of Fungi
- ClinicalTrials.gov ID
- NCT04984460
- Acronym / sponsor ID
- AHNantongU_YEZH_NTFS_V1.0
- Conditions
- Vaginitis
- Keywords
- Fluorescence morphological, liquid-based thin-layer film-making, Fungal vaginitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 30 Jul 2021 (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 purpose of this study is to compare the results of different detection methods for non-gestational fungal vaginitis (VVC), and to evaluate the significance of different fungal states in the results for diagnosis and treatment.
Detailed description
The study was divided into two phases: in the first phase, the vaginal secretions of 1000 enrolled patients with fungal vaginitis were detected with 3/4 different methods, and the sensitivity, specificity and consistency of these methods were compared; In the second stage, 1000 patients from the first stage were selected to meet the follow-up stage and divided into two groups. The test of Follow-up fungal culture and fluorescence morphological detection of liquid-based thin-layer film-making fungi were performed periodically. At last, the applicant will analyze the data, write the paper and publish the article.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| life-style counseling | – | Diagnostic Test: Fluorescence morphological detection of liquid-based thin-layer film-making fungiA sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased. Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients with suspected fungal vaginitis.
Key inclusion criteria (6 listed)
- 1. Samples from outpatient or inpatient clinics to be tested for fungal vaginitis.
- 2. A sample of one or more of the following characteristics. 2.1 Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased.
- 2.2 Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd.
- 3. The samples are vaginal secretions from the female body. Each sample should be the amount on one swab.
- 4. The sample is not in menstrual period.
Key exclusion criteria (3 listed)
- 1. Cases with incomplete specimen collection;
- 2. Mixed vaginitis cases;
- 3. Abscission cases with incomplete follow-up.
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 |
|---|---|---|
| Fluorescence morphological detection of liquid-based thin-layer film-making fungiSamples from outpatient or inpatient clinics to be tested for fungal vaginitis. A sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased. Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd. Samples are human vaginal secretions. Each sample should be the amount on one swab. The sample is not in menstrual period. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days. | Diagnostic test | life-style counseling |
Primary outcome
Comparing the positive detection rate of 3/4 different detection methods in the first phase.
Time frame: From Aug. 1st to Dec. 31st, 2021
The positive coincidence rate (sensitivity), negative coincidence rate (specificity) and total coincidence rate (consistency) was compared, according to the P<0.05 was used to determine whether it was statistically significant.
Calculating the proportion of the number of fungi in three different states in the map results of three/four detection methods.
Time frame: From Aug. 1st, 2021 to Jan. 31st, 2022
Counting The number and proportion of mycelia, spores and blastospores, especially the percentage of cases of single spore (+) in all cases of fungus (+).
Counting the positive numbers of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests and fungal culture in the Stage 2_follow-up stage.
Time frame: From Mar. 1, 2022 to Dec. 31st, 2022
the positive coincidence rate (sensitivity), negative coincidence rate (specificity) of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Individual participant dataSharing planned: No. Not planning sharing at present.
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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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.
Yuquan Zhang, Doctor principal investigator
Affiliated Hospital of Nantong University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginitis, run by Affiliated Hospital of Nantong University at 10 sites 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 6 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 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
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?
Comparing the positive detection rate of 3/4 different detection methods in the first phase. (time frame: From Aug. 1st to Dec. 31st, 2021). The study lists 3 primary outcomes in all. 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 30 Jul 2021.