Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples

NCT06598176 | Recruiting

• 1 other identifier: B3002023000030
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment.

Conditions

Uterine Cervical Neoplasm; Uterine Cervical Dysplasia; Human Papilloma Virus; HPV-Related Cervical Carcinoma

Keywords

biomarker; first-void urine; vaginal sample; screening; triage; self-sampling; prevention

Outcome Measures

Primary Outcomes (1)

• Detection of (epi)genetic biomarkers for cervical cancer and precancer

  A novel assay will be developed for the detection of the human papillomavirus (HPV) and epigenetic biomarkers to determine the presence of cervical (pre)cancer. Using histology outcomes as a reference test.

  48 months

Secondary Outcomes (3)

• Comparison of the biomarkers detected in the different sample types.

  48 months

• Demonstrate non-inferiority of the biomarker assay in self-samples compared to conventional cytology on pap smears.

  48 months

• Determine the predictive value of the biomarker assay and the long-term risk of cervical (pre)cancer

  Within 1 year after study completion

Study Arms (1)

Sample collection

EXPERIMENTAL

Women will collect one first-void urine sample and one vaginal self-sample at home, one day prior to a scheduled appointment at the hospital. During the hospital visit, an additional clinician collected cervical smear and a blood sample will be collected for the study. In case, the patient also undergoes a surgical intervention for their standard treatment plan, the tissue that is collected there, will also be used and analysed for our study. Cytology and histology results will be used as reference test.

Device: Colli-Pee 20mL device with UCM; Device: Evalyn Brush

Interventions

Colli-Pee 20mL device with UCM DEVICE

Women will collect a first-void urine (the initial part of the urine stream) sample at home the day before a hospital appointment using the 20mL Colli-Pee device prefilled with urine conservation medium (UCM, Novosanis, Belgium).

Sample collection

Evalyn Brush DEVICE

Women will collect a vaginal self-sample using the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home the day before a hospital appointment.

Sample collection

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• until 64 years old
• Diagnosed with cervical cancer (CIN3+, irrespective of stage) OR in need of conization (irrespective of diagnostic or therapeutic purposes)
• Has not started any form of cancer treatment prior to study enrollment
• Written informed consent must be obtained from patient
• Is able to understand the information brochure and what the study is about

You may not qualify if:

• Women that underwent hysterectomy
• Pregnant women or 6 weeks post-partum
• Treatment for cervical (pre)cancer in the last 6 months before participation in the study
• Participating in another interventional clinical study (where e.g., a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.
• Unable to give informed consent
• Patient has severe anaemia
• Patient received blood transfusion two weeks before sample collection
• Blood sampling would compromise patients' overall health
• Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
• Patients who are alcoholic or drug abusers
• Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator.

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator

Study Sites (1)

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Antwerpen, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

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; Precancerous Conditions

Study Officials

• Wiebren Tjalma, MD, PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Vorsters, Ir, PhD

CONTACT

032659130; alex.vorsters@uantwerpen.be

Eef van den Borst, MSc

CONTACT

032652665; eef.vandenborst@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2037
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)