Clinical Evaluation of the CINtec® Cytology Dual Stain Kit as a Screening Test as well as a Reflex Test in the Triage of Women with a Pap Cytology Result of ASC-US or LSIL

Clinical Evaluation of the CINtec® Cytology Dual Stain Kit as a Screening Test as well as a Reflex Test in the Triage of Women with a Pap Cytology Result of ASC-US or LSIL - The PALMS- Trial - "Primary, ASC-US, LSIL Marker Study"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00000408

Enrollment

27000

Registered

2010-05-14

Start date

2009-02-09

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

cervical cancer, High-grade lesion of cervix uteri N87.2

Interventions

Group 1: Pap cytology Group 2: CINtec Cytology Dual Stain Group 3: HR-HPV test

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Women undergoing a routine cervical cancer screening based on Pap cytology testing or women with a Pap cytology result of ASC-US or LSIL based on liquid-based cytology and evaluated according to the Bethesda classification system, Signed, written informed consent.

Exclusion criteria

Exclusion criteria: Women who are pregnant, Women with a history of hysterectomy (except a supracervical hysterectomy), Women who are unwilling or unable to provide informed consent and/or to adhere to study requirements.

Design outcomes

Primary

Measure	Time frame
Evaluation of the senitivity and specificity of CINtec cytology Dual Stain for identifying HGCIN (CIN2+/CIN3+) employing the quality-controlled histology diagnosis of cervical biopsies as gold standard.	—

Secondary

Measure	Time frame
Comparison of the sensitivity and specificity of CINtec Cytology Dual Staining for identifying HGCIN with the sensitivity and specificity of the follwing tests: - Pap cytology - HR-HPV test	—

Countries

Belgium, France, Germany, Italy, Spain

Contacts

Public ContactSusanne Rehm

mtm laboratories AG

rehm@mtmlabs.com+49 (0) 6221-64966-171

Outcome results

None listed

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