Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755517
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2021-04-23
First Post:
2021-02-04
Brief Title:
Effectiveness of Cervical Screening in Unvaccinated Herd Effect Protected Women HPV400
Sponsor:
Tampere University Hospital
Organization:
Tampere University Hospital
Study Overview
Official Title:
Effectiveness of Cervical Screening in Unvaccinated Herd Effect Protected Women - A Randomized Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPV400
Brief Summary:
To identify 1 Whether being informed infrequently results about screening is at least as a safe and b accurate as frequently obtaining all information from the present combination of opportunisticorganized cervical screening by comparing regimen results of two screening visits at the ages of 25 and 28 years Arm A1 vs results of one screening visit at the age of 28 years Arm A2 in unvaccinated herd effect protected women Unvaccinated frequently screened women who are not under herd effect protection will be controls C
Detailed Description:
Altogether 14000 1995-1997 born women resident in communities where herd effect against high-risk HPV infections was created with gender-neutral vaccination of birth cohorts 1992-1995 A-communities or not control C-communities in 2007-2010 with the bi-valent HPV1618 vaccine will be invited to participate a randomized screening trial at the ages of 25 and 28 years
Cervical samples will be analysed for HPV DNA with MGP Modified General Primer primer system followed by MALDITOFmatrix assisted laser desorption ionization-time of flight mass spectrometry mass spectrometry on the SEQUENOM translation of genomic science into solutions for molecular medicine and biomedical research platform HPV
With assumed 65 and 90 participation and retain rates the trial has 80 power to show non-inferiority of the infrequent vs the frequent screening information
At the study-end testing the null hypotheses of no difference in the incidence of the CIN23 cervical squamous intraepithelial neoplasia 23 end-points comparing the A1 vs C and A2 vs C intervention arms will be done using the Mantel-Haenszel one degree of freedom chi-square statistics
Work Content Letters of invitation to visit cervical screening at the nearest FICAN Comprehensive Cancer Center Finland-Mid study site will be send to the approximately 14000 unvaccinated women at the ages of 25 and 28 years Following informed consent cervical liquid-based cytology samples will be taken for HPV DNA andor cytology screening at study visits
All cytological screening results will be communicated to Arm A1 and Arm C study participants Arm A2 participants will get the test results at the age of 28 However results of the cytology testing indicative of colposcopy according to local standard of care and currently accepted EU the European Union -guidelines Käypä Hoito 2010 Franceschi et al 2011 will be immediately communicated to all study participants HPV DNA results will be communicated to all study participants at the study end Pertinent colposcopy referrals to organized health care will be made
All study participants will be offered a possibility to give an oropharyngeal sputum sample after 30 seconds gargling of sterile physiological saline 5 ml for HPV PCR polymerase chain reaction analysis
Cervical samples will be analysed for HPV DNA with MGP Modified General Primer primer system followed by MALDITOFmatrix assisted laser desorption ionization-time of flight mass spectrometry mass spectrometry on the SEQUENOM translation of genomic science into solutions for molecular medicine and biomedical research platform HPV
With assumed 65 and 90 participation and retain rates the trial has 80 power to show non-inferiority of the infrequent vs the frequent screening information
At the study-end testing the null hypotheses of no difference in the incidence of the CIN23 cervical squamous intraepithelial neoplasia 23 end-points comparing the A1 vs C and A2 vs C intervention arms will be done using the Mantel-Haenszel one degree of freedom chi-square statistics
Work Content Letters of invitation to visit cervical screening at the nearest FICAN Comprehensive Cancer Center Finland-Mid study site will be send to the approximately 14000 unvaccinated women at the ages of 25 and 28 years Following informed consent cervical liquid-based cytology samples will be taken for HPV DNA andor cytology screening at study visits
All cytological screening results will be communicated to Arm A1 and Arm C study participants Arm A2 participants will get the test results at the age of 28 However results of the cytology testing indicative of colposcopy according to local standard of care and currently accepted EU the European Union -guidelines Käypä Hoito 2010 Franceschi et al 2011 will be immediately communicated to all study participants HPV DNA results will be communicated to all study participants at the study end Pertinent colposcopy referrals to organized health care will be made
All study participants will be offered a possibility to give an oropharyngeal sputum sample after 30 seconds gargling of sterile physiological saline 5 ml for HPV PCR polymerase chain reaction analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None