A clinical study of intraoperative diagnosis of sentinel lymph node metastasis in head and neck cancer patients using bimolecular methods

A clinical study of intraoperative diagnosis of sentinel lymph node metastasis in head and neck cancer patients using bimolecular methods - Intraoperative diagnosis of lymph node metastasis in head and neck cancer patients using one-step nucleic acid amplification

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006508

Enrollment

Registered

2011-10-12

Start date

2008-12-01

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

Oral cancer

Interventions

We evaluate the lymph node metastasis in head and neck cancer patients using bimolecular methods.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Previously untreated head and neck squamous cell carcinoma patients who surgical resection are indicated as a primary treatment, are the candidates for our study.

Exclusion criteria

Exclusion criteria: 1)Previously treated patients 2)Patients judged by the investigator to be unfit to be enrolled into the study

Design outcomes

Primary

Measure	Time frame
We evaluate the concordance rate between the OSNA assay and histopathology for lymph node metastases.	—

Secondary

Measure	Time frame
Cutoff values to distinguish macrometastasis, micrometastasis, and nonmetastasis are determined by measuring cytokeratin 19 (CK19) mRNA in histopathologically positive and negative lymph nodes using OSNA.	—

Countries

Japan

Contacts

Public ContactYasuhisa Hasegawa

Aichi Cancer Center Department of Head and Neck Surgery

hasegawa@aichi-cc.jp052-762-6111

Outcome results

None listed

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