VVC Sampling Study for Analysis Validation

NCT05327192 | Completed

• 1 other identifier: CL4-2
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC. The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms. Vaginal samples will be examined under a microscope for yeast forms (hyphae or pseudohyphae) or budding yeast. If the Investigator assesses that the patient has VVC, based on examination and the potassium hydroxide (KOH) test, two vaginal secretion samples will be collected by a vaginal swab. One sample will be cultured to verify the presence of Candida and the other will be used for sequencing analysis of the vaginal microbiome. Samples from a total of 10 women are planned to be taken.

Conditions

Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

• Correlation between vaginal sample DNA sequencing and VVC confirmed by clinical diagnosis and culture.

  1 day

Other Outcomes (1)

• Evaluate resolution of bacterial DNA sequencing using 16S regions.

  1 day

Interventions

No intervention, only sampling OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.

You may qualify if:

• Adult women aged 18 years or older
• Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:
• At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.
• Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
• Having decisional capacity and providing written informed consent
• Signed informed consent and willing and able to comply with all study requirements

You may not qualify if:

• None

Sponsors & Collaborators

• Gedea Biotech AB: lead

Study Sites (2)

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Research and Development Department, Berkshire Healthcare NHS Foundation Trust

Slough, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal samples to study bacterial DNA

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: May 12, 2022
• Primary Completion: July 6, 2022
• Study Completion: July 6, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)