Uterine Cervical Neoplasms Clinical Trial
Official title:
Improving Access to Cervical Cancer Screening for Women Living in Precarious Conditions Met Within Doctors of the World Programs
Verified date | January 2019 |
Source | Médecins du Monde |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Every year, in France, 3 000 women are diagnosed with cervical cancer, and 1 000 die each
year. Recent studies highlighted regional, social and economical inequalities with respect to
cervical cancer incidence.
In France, the pap-smear test is currently the reference test in order to screen for cervical
cancer and neoplasia (CIN). Screening and treatment reduced the incidence and the mortality
due to cervical cancer by half in the two last decades. That said, many women are still not
reached by prevention programs, especially women living in precarious conditions. In 2013,
Doctors of the World France estimated that almost 70% of women aged 25 to 65 years old
visiting its medical facilities had never had of a pap-smear test.
The main study objectives are :
Primary objective
To compare the proportion of individuals with abnormal cytology across two screening
strategies in order to determine which strategy detects a greater proportion of individuals
with abnormal cytology.
These two strategies consist of a preventive consultation followed by:
1. Direct patient referral for Pap smear testing in a partner health facility ('Pap smear'
study arm)
2. An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by
patient referral for Pap smear testing in a partner health facility if the HPV-HR test
is positive* ('self-collected vaginal swab for HPV-HR testing + Pap smear triage' study
arm) *A women who tests negative for HPV-HR can still be referred for further Pap smear
testing, or can be referred for a gynaecological consultation for any other reason.
First of secondary objectives:
To evaluate the proportion of individuals who completed cervical cancer screening in each
study arm in order to determine which strategy resulted in greater screening participation.
The above clarification of the study objectives and the related changes in the study
protocole have been approved by the Comité de Protection des Personnes Ile de France IV.
Status | Active, not recruiting |
Enrollment | 1258 |
Est. completion date | August 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Women between 25 and 65 years old - Met within Doctors of the World programs Exclusion Criteria: - History of total hysterectomy (= ablation of uterus and cervix) - Never had sexual intercourse - Last pap smear test made during the three last years (ou first pap smear test during the last year) |
Country | Name | City | State |
---|---|---|---|
France | Médecins du Monde | Paris | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Médecins du Monde | National Cancer Institute, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of women with abnormal cytology | Comparison of the proportion of women with abnormal cytology in each study arm | 4 months after the inclusion | |
Secondary | Proportion of women who completed cervical screening | Comparison of the proportion of women who completed cervical screening in each study arm | 4 months after the inclusion | |
Secondary | Proportion of women who acquired a specific set of knowledge about cervical cancer before and after the preventive consultation | Comparison of the proportion of women who acquired a specific set of knowledge before and after the preventive consultation, using the same five-item questionnaire | At baseline (before and after the preventive consultation) | |
Secondary | Social determinants of completing cervical screening | Comparisons of medical, socio-demographical and educational characteristics of women who completed screening with that of women who did not. | At baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03225443 -
Observation and Evaluation of Short-term Curative Effect of Local Advanced Cervical Cancer Treated With Particle Radiotherapy Versus Neoadjuvant Chemotherapy
|
N/A | |
Recruiting |
NCT01373723 -
Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer
|
N/A | |
Completed |
NCT02808832 -
An HPV Vaccine Provider Intervention in Safety Net Clinics
|
N/A | |
Terminated |
NCT01234480 -
Intended Use Study of the BD SurePath Plus™ Pap
|
||
Terminated |
NCT01194609 -
A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT01075412 -
FLT PET Imaging for Cervical Cancer
|
Phase 2 | |
Completed |
NCT01014026 -
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
|
Phase 3 | |
Completed |
NCT02865889 -
Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications
|
N/A | |
Completed |
NCT00377845 -
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
|
Phase 0 | |
Recruiting |
NCT05531981 -
Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer
|
||
Recruiting |
NCT05393440 -
First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer
|
Phase 1 | |
Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
Completed |
NCT02866006 -
Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03270995 -
Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study
|
N/A | |
Completed |
NCT02320578 -
2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial
|
N/A | |
Terminated |
NCT02900248 -
CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
|
||
Not yet recruiting |
NCT05065853 -
Urinary and Vaginal HPV Testing in Cervical Cancer Screening
|
||
Completed |
NCT01231945 -
Low-Cost Molecular Cervical Cancer Screening Study
|
N/A | |
Completed |
NCT01717391 -
[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers
|
Phase 2 | |
Active, not recruiting |
NCT04947605 -
Epidemiological Landscape of Cervical Cancer in Latin America
|