A prospective multicenter study for evaluation of the accuracy and clinical usefulness of the high-sensitivity next-generation sequencing panel using cytological specimens from lung cancer

A prospective multicenter study for evaluation of the accuracy and clinical usefulness of the high-sensitivity next-generation sequencing panel using cytological specimens from lung cancer - cPANEL trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047215

Enrollment

260

Registered

2022-03-18

Start date

2022-03-18

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

lung cancer

Interventions

Cytology specimens (brushing cytology, needle aspiration washing solution, and pleural effusion) will be collected and stored in a nucleic acid stabilizer during examination or after procedure.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who are suspected of having lung cancer (lung adenocarcinoma) and require cytology or histological diagnosis. 2) Patients over 20 years old. 3) Patients for whom the subject has given written consent to participate.

Exclusion criteria

Exclusion criteria: Exclusion criteria (primary registration) 1) Patients whom the principal investigator (physician) or sub investigator (physician) determines to be inappropriate to participate in this study. Exclusion criteria (secondary registration) 1) If the lesion is a benign disease (organizing pneumonia, infection, etc.) 2) When malignant disease is suspected but no malignant cells are detected in a paired cytology specimen 3) If it was a metastatic lung tumor (e.g., lymphoma, gastrointestinal cancer, breast cancer lung metastasis)

Design outcomes

Primary

Measure	Time frame
The primary endpoint was to confirm the superiority of the high-sensitivity multigene NGS panel using cytology specimens compared with the conventional gold-standard method at a 90% success rate	—

Secondary

Measure	Time frame
1) Comparison of positive concordance rate and positive predictive value of gene mutation of "companion diagnostic test" and "high-sensitivity lung cancer multi-gene NGS panel test" for cytological specimens 2) Detection rate of gene abnormalities of 8 lung cancer-related genes (EGFR, BRAF, ALK, ROS1, MET, RET, KRAS, HER2) by "high-sensitivity lung cancer multi-gene NGS panel test" for cytological specimens 3) Number of days for reporting test results of "High-sensitivity lung cancer multigene NGS panel test" for cytological specimens	—

Measure

Time frame

1) Comparison of positive concordance rate and positive predictive value of gene mutation of "companion diagnostic test" and "high-sensitivity lung cancer multi-gene NGS panel test" for cytological specimens 2) Detection rate of gene abnormalities of 8 lung cancer-related genes (EGFR, BRAF, ALK, ROS1, MET, RET, KRAS, HER2) by "high-sensitivity lung cancer multi-gene NGS panel test" for cytological specimens 3) Number of days for reporting test results of "High-sensitivity lung cancer multigene NGS panel test" for cytological specimens

—

Countries

Japan

Contacts

Public ContactKei Morikawa

St. Marianna University School of Medicine Division of Respiratory Diseases, Department of Internal Medicine

mokke@marianna-u.ac.jp+81449778111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026