Cervical Cancer Clinical Trial
— ASTRAOfficial title:
Benefit of Self-sampling for HPV DNA in a General Practitioner's Office to Improve Participation in Cervical Screening - The ASTRA Study.
NCT number | NCT06253169 |
Other study ID # | V01 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2024 |
Est. completion date | June 2025 |
One of the limitations of organized cervical screening in the Czech Republic is the lack of participation in preventive gynecological examinations. The aim of the project is to evaluate the benefits of self-sampling for HPV DNA in general practitioners' outpatient clinics to improve population participation in cervical screening.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | June 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent for statistical data processing and consent to the processing of personal data - Age 30+ - HPV test never performed or performed more than 3 years ago or patient does not know Exclusion Criteria: - Refusal to participate - Pregnancy and puerperium - Menses - History of hysterectomy - HPV test performed <3 years ago with negative result - Regular participation in screening and concurrent age 35, 45 or 55 years (test will be performed in the same year of screening). |
Country | Name | City | State |
---|---|---|---|
Czechia | CGOP, s.r.o. | Prague | |
Czechia | Department of Gynecology, Obstetrics and Neonatology, General University Hospital, First Faculty of Medicine, Charles University | Prague |
Lead Sponsor | Collaborator |
---|---|
Patient Organization Veronica |
Czechia,
Ngo O, Chloupkova R, Cibula D, Slama J, Mandelova L, Hejduk K, Hajduch M, Minka P, Koudelakova V, Jaworek H, Trnkova M, Vanek P, Dvorak V, Dusek L, Majek O. Direct mailing of HPV self-sampling kits to women aged 50-65 non-participating in cervical screening in the Czech Republic. Eur J Public Health. 2024 Apr 3;34(2):361-367. doi: 10.1093/eurpub/ckad229. — View Citation
Sehnal B, Slama J. What next in cervical cancer screening? Ceska Gynekol. 2020 Winter;85(4):236-243. — View Citation
Slama J, Dvorak V, Trnkova M, Skrivanek A, Hrabcova K, Ovesna P, Novackova M. Is phased implementation of HPV testing and triage with dual staining the way to transform organized cytology screening? Eur J Cancer Prev. 2024 Mar 1;33(2):168-176. doi: 10.1097/CEJ.0000000000000844. Epub 2023 Sep 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall. | To compare the proportion of women who self-test for HPV DNA in a GP office versus those who refuse to take the test. To assess the overall proportion of women who self-test and the proportion in each study cohort. | Through study completion, an average of 1 year | |
Primary | Evaluation of the frequency of positivity of the HPV tests taken. | Compare the proportion of women who will self-test positive for HPV DNA, including an assessment of positivity for HPV 16/18 and other HPV genotypes. To assess the overall proportion of women testing positive and the proportion in each study cohort. | Through study completion, an average of 1 year | |
Primary | Evaluation of follow-up gynaecological care in women who tested positive. | To assess what proportion of women who self-test positive for HPV DNA will accept a gynecologic exam and to assess the results of the gynecologic visit. | Through study completion, an average of 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06223308 -
A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT03367871 -
Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04537156 -
Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
|
Phase 3 | |
Recruiting |
NCT03668639 -
Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Withdrawn |
NCT04806945 -
A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
|
Phase 3 | |
Active, not recruiting |
NCT04185389 -
Long-Term Follow-Up of HPV FOCAL Participants
|
||
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
Completed |
NCT05120167 -
Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy
|
N/A | |
Recruiting |
NCT05483491 -
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
|
Phase 1 | |
Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
Completed |
NCT05862844 -
Promise Women Project
|
N/A | |
Recruiting |
NCT04934982 -
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)
|
N/A | |
Recruiting |
NCT03876860 -
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
|
N/A | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Completed |
NCT00543543 -
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
|
Phase 3 | |
Terminated |
NCT04864782 -
QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT04226313 -
Self-sampling for Non-attenders to Cervical Cancer Screening
|
N/A |