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

NCT02916368 | Unknown DMC

• 1 other identifier: PDHNSCC-01609
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Squamous Cell

Outcome Measures

Primary Outcomes (1)

• survival rate

  3 years

Study Arms (2)

with surgery

with chemotherapy or radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Capital Medical University

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 27, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: September 28, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share