HPV in Blood Samples From Cervical Cancer Patients.

NCT03749720 | Completed

• 1 other identifier: U416
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 2

Brief Summary

By means of digital droplet PCR (ddPCR) anf targeted Next Generation Sequencing (NGS), this study examines blood samples from patients newly diagnosed with cervical cancer to investigate whether it is possible to measure the presence and amount of HPV DNA in these blood samples. The first blood sample is taken at time of diagnosis, and follow-up blood samples are collected during treatment- and follow-up visits. We expect to find a correlation between the disease stage and the viral load and also a decline in viral load after treatment. Furthermore, we hope that this method may serve as a way of detecting disease recurrence earlier than what is possible today.

Conditions

HPV-Related Carcinoma; HPV-Related Malignancy

Keywords

Cervical Cancer; HPV; Pathology; ddPCR

Outcome Measures

Primary Outcomes (1)

• HPV DNA

  A qualitative and quantitative measure of HPV DNA in blood samples.

  Two years

Study Arms (1)

Cervical cancer patients

OTHER

Baseline- and follow-up blood samples are collected from the cervical cancer patients at time of diagnosis and during treatment and clinical follow-up. HPV DNA is measured in these samples.

Other: Blood sample

Interventions

Blood sample OTHER

Blood sample taken from cervical cancer patients at time of diagnosis (baseline) and follow-up visits.

Cervical cancer patients

Eligibility Criteria

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

You may qualify if:

• Diagnosed with cervical cancer ≥ stage 1B between june 2018 and june 2020
• \> 18 years of age at the time of diagnosis
• There must be available cervical tissue material from the patient to analyse for HPV
• Women \> 18 years with no prior history of any cervical dysplasia
• Women \> 18 years
• Must have a histologically verified severe cervical dysplasia (CIN3)
• Is admitted for cervical conisation

You may not qualify if:

• \< 18 years of age at time of cervical cancer diagnosis
• Cervical cancer \< stage 1B
• \< 18 years of age
• Prior cervical dysplasia
• \< 18 years of age
• Women with only low grades of cervical dysplasia (CIN1 or CIN2)
• Women with HPV-negative cervical biopsies

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Department of Obstetrics and Gynecology

Aarhus, 8200, Denmark

Location

Department of Obstetrics and Gynecolgy

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sara Bønløkke, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case-control study with 141 case patients newly diagnosed cervical cancer and a control group of 10 healthy women with no prior cervical dysplasia and 25 women with cervical dysplasia (CIN3), respectively.

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 21, 2018
• Study Start: June 15, 2018
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: April 1, 2025

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)