PTM-TK: Non interventional study on the implementation of quantitative determination of DRH1 antibody (AB) equivalents in serum by using the DRH1 antibody clone with PT Monitor® as part of therapy control in patients with HPV16-induced vulva- and cervical tumors

PTM-TK: Non interventional study on the implementation of quantitative determination of DRH1 antibody (AB) equivalents in serum by using the DRH1 antibody clone with PT Monitor® as part of therapy control in patients with HPV16-induced vulva- and cervical tumors - PTM-TK

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00019187

Enrollment

200

Registered

2019-12-30

Start date

2020-01-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C51 C53

Interventions

Group 1: Patients with HPV16 induced vulva carcinoma or pre-cancer stages requiring treatment and patients with HPV induced cervical carcinoma or pre-cancer stages requiring treatment wil come to thei

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. >18 years 2. Willingness and ability to submit declaration of consent after receiving relevant information, and signed declaration of consent 3. Consent to compliance with the required follow-up appointments 4. Diagnosis of HPV16-induced vulva carcinoma or pre-cancer requiring treatment 5. Diagnosis of an HPV16-induced cervical carcinoma or pre-cancer requiring treatment 6. Positive Prevo Check® result at day of hospital admittance and positive PT Monitor® result at start of therapy t0 (= 7 days before to 7 days after initial therapeutic intervention to remove tumor) 7. Therapy of HPV16-positive tumor not started before t0.

Exclusion criteria

Exclusion criteria: 1. An operative or medical condition that would expose the patient to increased risk from the study. The investigator will make the decision based on the patient's history and/or clinical picture or lab values. 2. Lack of willingness and ability to provide declaration of consent 3. Patients who have been vaccinated against HPV. Patients who have been vaccinated against HPV show a positive concentration of antibodies against HPV16 L1 (equals DRH1 antibody equivalents) due to the immunisation by the vaccination 4. Patients who are vaccinated against HPV during the study period 5. Patients with diagnosed HPV16 tumor whose therapy has already started before the start of this study. 6. Participation in a concurrent study with the exception of observational studies 7. HIV-positive patients

Design outcomes

Primary

Measure	Time frame
Percent change in the titer of DRH1 AB equivalents in serum relative to the individual baseline (t0 = therapy start) over a period of 48 weeks after therapy start. Determination of minimal clinically important differences (MCID) of DRH1 antibody equivalents in the course of therapy compared with the concentration of DRH1 antibody equivalents at therapy start for assessment of the treatment success in HPV16-induced tumors.	—

Measure

Time frame

Percent change in the titer of DRH1 AB equivalents in serum relative to the individual baseline (t0 = therapy start) over a period of 48 weeks after therapy start. Determination of minimal clinically important differences (MCID) of DRH1 antibody equivalents in the course of therapy compared with the concentration of DRH1 antibody equivalents at therapy start for assessment of the treatment success in HPV16-induced tumors.

—

Countries

Germany

Contacts

Public ContactAmr Soliman

Universitätsklinik für Gynäkologie und Geburtshilfe Klinikum Oldenburg AöR

amr.soliman@uni-oldenburg.de+49 441 403 2288

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026