The Clinical Study of the Poorly Differentiated Head and Neck Squamous Cell Carcinoma

September 27, 2016 updated by: Zhigang Huang, Beijing Tongren Hospital

The Clinical Study of the Poorly Differentiated Head and Neck Squamous Cell

Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck malignant tumors .Investigators found that several patients with early TNM stage and poor differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis factors and survival rates probably related to the differentiation of HNSCC, and prognosis factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.

Study Overview

Status

Unknown

Conditions

Detailed Description

Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck malignant tumors. Investigators found that several patients with early TNM stage and poor differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis factors and survival rates probably related to the differentiation of HNSCC, and prognosis factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.

About this study ,inclusion criteria were the following parts:

the patients of poor differentiated HNSCC ; T1-4aN0-2M0; pathological examination: poor differentiated squamous cell carcinoma; initial treatment(primary, without surgery, radiotherapy and chemotherapy); range:18-70 years old; KPS>80; hemogram and the function of main organ such as heart, lung, liver and kidney were normal; having the endoscopy, CT and MRI before formed into different groups; sign the informed consent file, good compliance.

AND the exclusion criteria were:

uncontrollable epileptic seizure, disorder of central nervous system or unconsciousness cause by psychosis; serious and uncontrollable infection; main organ system failure (including heart ,lung ,liver and kidney); reject training; high and moderate differentiated squamous cell carcinoma

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population were those patients with poor differentiated HNSCC from 18 to 70 years old,be in the stage of T1-4aN0-2M0 and the pathological examination shows poor differentiated squamous cell carcinoma ,also be willing take part in this study of treatment. The function of their main organ such as heart, lung, liver and kidney were normal and having the endoscopy, CT and MRI before formed into different groups.

Description

Inclusion Criteria:

  • Patients of poor differentiated HNSCC ;
  • Patients within the stage of T1-4aN0-2M0;
  • The pathological examination of the patients show poor differentiated squamous cell carcinoma;
  • Patients with initial treatment(primary, without surgery, radiotherapy and chemotherapy);
  • 18-70 years old;
  • KPS>80;
  • Hemogram and the function of main organ such as heart, lung, liver and kidney were normal
  • Having the endoscopy, CT and MRI Signed the informed consent file, good compliance.

Exclusion Criteria:

  • Uncontrollable epileptic seizure, disorder of central nervous system or unconsciousness cause by psychosis;
  • Serious and uncontrollable infection;
  • Main organ system failure (including heart ,lung ,liver and kidney); reject training;
  • High and moderate differentiated squamous cell carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
with surgery
with chemotherapy or radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival rate
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDHNSCC-01609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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