One-step Nucleic Acid Amplification for Detecting Lymph N... | NCT02852343

Studies
One-step Nucleic Acid Amplification for Detecting Lymph Node Metastasis of Head and Neck Squamous Cell Carcinoma

NCT02852343

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Sep 11, 2018Actual

Enrollment

26Actual

Phase

Not provided

Conditions

cN0 Oral Squamous Cell Carcinomas

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2015Actual

Primary Completion Date

Dec 21, 2016Actual

Completion Date

Dec 21, 2016Actual

First Submitted Date

Jul 19, 2016

First Submission Date that Met QC Criteria

Jul 28, 2016

First Posted Date

Aug 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2018

Last Update Posted Date

Sep 11, 2018Actual

Description Module

Brief Summary

The investigators main objective is to show that OSNA technique is as accurate as pathological analysis (frozen section / HE staining and immunochemistry) to detect occult lymph node metastasis (micro and macrometastasis).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of CK19 mRNA copies/µL of diluted lymph node lysate		through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient > 18 years old
Head and neck squamous cell carcinoma diagnosed by biopsy
N0 classification (N0: no lymph node invasion on clinical and radiological examination).
Neck dissection or sentinel lymph node biopsy required to treat the patient
ECOG 1,2 or 3
Patient's consent

Exclusion Criteria:

Patient previously treated by radiotherapy or surgery for head and neck neoplasm.
Contraindication or patient unwillingness to undergo surgical treatment
Incapacitated adults

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with sceduled procedure to cN0 oral squamous cell carcinomas

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier universitaire de Rennes		Rennes		35000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32004908	Derived	Peigne L, Godey F, Le Gallo M, Le Gall F, Fautrel A, Morcet J, Jegoux F. One-step nucleic acid amplification for detecting lymph node metastasis of head and neck squamous cell carcinoma. Oral Oncol. 2020 Mar;102:104553. doi: 10.1016/j.oraloncology.2019.104553. Epub 2020 Jan 28.