Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582654
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Normalizing Antibody Detection in First-void Urine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
URINORM Normalizing Antibody Detection in First-void Urine
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
URINORM
Brief Summary:
The aim of this study is to develop robust analytical protocols for the monitoring of vaccine induced immunity against the Human Papillomavirus HPV in first-void urine samples and to examine fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts
Detailed Description:
To date invasive clinician-collected cervical samples blood and vaginal samples are still the primary methods to monitor disease and immune responses to vaccine-preventable genital tract infections Replacing these samples with a specimen that is non-invasive and can be self-collected at home could have important acceptance and feasibility advantages and could facilitate the logistics of clinical trials and future epidemiological studies Initial results of experiments using first-void urine samples for immune response monitoring are promising However overall standardization and normalization of fluctuation in signals are necessary for it to become a suitable genital tract liquid biopsy in vaccine research Therefore the aim of this study is to normalize antibody detection in first-void urine by reducing sample variability using the human papillomavirus HPV as a model
A total of 150 participants will be included consisting of six different cohorts including a group of pre-adolescent girls n25 a group of young women using ovulation-influencing contraceptives n25 a group of young women using non-ovulation-influencing contraceptives n25 a group of young women using no contraceptives n25 a group of post-menopausal women n25 and a group of men n25 Participants will be followed over a period of 36 days and will be asked to self-collect 6 to 21 first-void urine samples depending on cohort using a Colli-Pee 20mL Novosanis Moreover participants will have two scheduled visits day 1 and 36 of the study at the study site where each time a blood collection 1x 5-10cc will be performed
Collected first-void urine and serum samples will be analyzed for menstrual cycle-related fluctuations and between-group differences in HPV-specific antibody levels Moreover to compare immunological with viral endpoints HPV DNA detection and genotyping will be performed on the first-void urine sample and samples will be tested for various biomarkers that might be valuable for the normalization of inter- and intra-individual variability
A total of 150 participants will be included consisting of six different cohorts including a group of pre-adolescent girls n25 a group of young women using ovulation-influencing contraceptives n25 a group of young women using non-ovulation-influencing contraceptives n25 a group of young women using no contraceptives n25 a group of post-menopausal women n25 and a group of men n25 Participants will be followed over a period of 36 days and will be asked to self-collect 6 to 21 first-void urine samples depending on cohort using a Colli-Pee 20mL Novosanis Moreover participants will have two scheduled visits day 1 and 36 of the study at the study site where each time a blood collection 1x 5-10cc will be performed
Collected first-void urine and serum samples will be analyzed for menstrual cycle-related fluctuations and between-group differences in HPV-specific antibody levels Moreover to compare immunological with viral endpoints HPV DNA detection and genotyping will be performed on the first-void urine sample and samples will be tested for various biomarkers that might be valuable for the normalization of inter- and intra-individual variability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None