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

NCT ID: NCT02916368

Last Updated: 2016-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-01-31

Brief Summary

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.

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

Conditions

Carcinoma, Squamous Cell

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

with surgery

No interventions assigned to this group

with chemotherapy or radiotherapy

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhigang Huang

Capital Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PDHNSCC-01609

Identifier Type: -

Identifier Source: org_study_id