NCT02879968

Brief Summary

Correlation between serum squamous cell carcinoma antigen level and tumor volume in Head and Neck Cancer is to determine a correlation between level of serum squamous cell carcinoma antigen and tumor volume in Head and Neck Caner measured by cross-sectional imaging.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

August 23, 2016

Last Update Submit

March 2, 2020

Conditions

Head and Neck Cancer

Keywords

serum squamous cell carcinoma antigentumor volumeHead and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Correlation between serum squamous cell carcinoma antigen and tumor volume

    2 weeks

Study Arms (1)

Head and Neck squamous cell carcinoma

A single measurement of serum squamous cell carcinoma antigen level is performed in the eligible Head and Neck squamous cell carcinoma patients. The study tool measuring serum squamous cell carcinoma antigen level is ARCHITECT SCC (Abbott). The gross tumor volume in the cross sectional imaging obtained within 2 weeks of each patient is calculated with the typical ellipsoid formula.

Other: Non-interventional study

Interventions

Non-interventional studyOTHER
Head and Neck squamous cell carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Head and Neck squamous cell carcinoma

You may qualify if:

  • Histologically proven squamous cell carcinoma in Head and Neck
  • Getting a cross-sectional imaging of Head and Neck within 2 weeks of collecting serum squamous cell carcinoma antigen

You may not qualify if:

  • Metastatic disease
  • Accompanied Non-Head and Neck squamous cell carcinoma
  • Nasopharyngeal, thyroid, salivary, nose and paranasal sinus carcinoma
  • Skin disease: eczema, erythrodermic epidermitis, pemphigus, and psoriasis
  • Pulmonary disease: tuberculosis, adult respiratory distress syndrome, pulmonary infiltration with eosinophilia, sarcoidosis, and bronchogenic cyst
  • Renal failure
  • Using antihistamine eye drops

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hadyai, Changwat Songkhla, 90110, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum squamous cell carcinoma antigen

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)