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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04984460
Other study ID # AHNantongU_YEZH_NTFS_V1.0
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 9, 2021
Est. completion date April 1, 2023

Study information

Verified date July 2021
Source Affiliated Hospital of Nantong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date April 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 14 Years to 70 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 1. Cases with incomplete specimen collection; - 2. Mixed vaginitis cases; - 3. Abscission cases with incomplete follow-up.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Fluorescence morphological detection of liquid-based thin-layer film-making fungi
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.

Locations

Country Name City State
China The First Affiliated Hospital of Ustc Hefei Anhui
China Jiujiang Maternal and Child Health Hospital Jiujiang Jiangxi
China Jiangxi Maternal and Child Health Hospital Nanchang Jiangxi
China Affiliated Hospital of Nantong University Nantong Jiangsu
China Affiliated Nantong Hospital Of Shanghai University Nantong Jiangsu
China Nantong Maternal and Child Health Hospital Nantong Jiangsu
China The Second Affiliated Hospital of Nantong University Nantong Jiangsu
China Children's Hospital of Fudan University Qidong Branch Qidong Jiangsu
China Changning District Maternal and Child Health Care Hospital Shanghai Shanghai
China Zhongshan City People's Hospital Zhongshan Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From Aug. 1st to Dec. 31st, 2021
Primary 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 (+). From Aug. 1st, 2021 to Jan. 31st, 2022
Primary 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 From Mar. 1, 2022 to Dec. 31st, 2022
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