Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention

NCT01588301 | Completed Early Phase 1

• 1 other identifier: INCA08-KH / APACHE-2
• Study Type: interventional
• Target: 5,998
• Locations: 0 countries
• Sites: N/A

Brief Summary

Scientific Context: High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. The two main ways are to reach the 7 million underscreened women (organized screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. The performance of the SCVS to detect cervical HPV infection has been assessed by the first part of the whole study: APACHE-1. The goal of this study is to compare the attitudes of women not attending organized cervical cancer screening face to different strategies: further invitation to make a cervical smear or kit for self-collected vaginal sample sent at home. Description of the project : Nine months after a primary invitation to make a cervical smear, a random sample of 6000 women not attending organized cervical cancer screening will be randomly assigned to one of the following arms:

• Intervention arm 1: Women will receive a further invitation to make a cervical smear
• Intervention arm 2: Women will be directly sent the kit for self-collected vaginal sample at home. The women who will send the self-sample to the laboratory for analyse will receive their results at home as well as their general practitioner if the HPV DNA test is positive (infection by a high-risk HPV). For them who will have a HPV DNA test positive, it will be necessary to complete the screening action with a cervical smear. That's why those women will receive an invitation to make a cervical smear if they won't do it during the 9 months following the first mail.
• Control arm: Those women will receive complete information about the study, the main results and the screening recommendations at the end of the study.

Conditions

Cervical Cancer; Human Papillomavirus Infection

Keywords

Cervical Cancer Screening; Human Papillomavirus (HPV); Self-collected vaginal sample; Cervical Smear

Outcome Measures

Primary Outcomes (1)

• Comparison of women's attitude according to the arm: participation or not to a whole screening action

  Comparison of attitudes among women not attending organized cervical cancer according to the type of intervention or the lack of intervention: participation or not to a whole screening action. Are considered as whole screening action: * cervical smear * HPV DNA testing on self-collected vaginal sample negative (no infection by a high-risk HPV) * HPV DNA testing on self-collected vaginal sample positive (infection by a high-risk HPV) followed by a cervical smear

  9 months after the beginning of the study (sending of mails)

Secondary Outcomes (2)

• Analysis in sub-groups

  9 months after the beginning of the study (sending of mails)

• Identification of the psychological determinants and mechanisms (checks and motivational factors)

  9 months after the beginning of the study (sending of mails)

Study Arms (3)

Group 1 : Further invitation by mail

EXPERIMENTAL

Further invitation to attend for cervical cytology

Behavioral: Attending for cervical cytology

Group 2 : Kit for Self-collected vaginal sample

EXPERIMENTAL

Kit for Self-collected vaginal sample sent at home and then test for Human Papillomavirus (HPV)

Behavioral: Kit for Self-collected vaginal sample

Group 3: Control

NO INTERVENTION

Interventions

Attending for cervical cytology BEHAVIORAL

A further invitation to attend for cervical cytology are going to be sent by mail to women

Group 1 : Further invitation by mail

Kit for Self-collected vaginal sample BEHAVIORAL

Kit for self-collected vaginal sample are going to be directly sent at women's home

Group 2 : Kit for Self-collected vaginal sample

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women from 30 to 65 years
• Living in Indre-et-Loire (french territorial division 37)

You may not qualify if:

• Women who attend organized cervical cancer screening or who answer to the invitation
• Cervical smear made in the three last years
• HPV linked cervical condition undergoing treatment
• Hysterectomy (including cervix)

Sponsors & Collaborators

• University Hospital, Tours: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Interventions

Receptor Protein-Tyrosine Kinases

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Ken HAGUENOER

  François Rabelais University, Public Health Laboratory, Tours, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: April 30, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 12, 2014

Record last verified: 2014-07