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出境医 / 临床实验 / The Prognostic Value of Human Papilloma Virus in Nasopharyngeal Carcinoma
The Prognostic Value of Human Papilloma Virus in Nasopharyngeal Carcinoma
Study Description
Brief Summary:
It is well established that HPV infection has a casual and is a prognostic factor in several cancer types, including oropharynx. We wish to examine if HPV infection has a prognostic significance in nasopharyngeal carcinoma.
| Condition or disease |
|---|
| Nasopharyngeal Carcinoma |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | The Prognostic Value of Human Papilloma Virus in Nasopharyngeal Carcinoma |
| Estimated Study Start Date : | July 20, 2019 |
| Estimated Primary Completion Date : | July 2020 |
| Estimated Study Completion Date : | December 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Overall survival [ Time Frame: 6 months ]
Biospecimen Retention: Samples Without DNA
Histopathological slides
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients diagnosed with nasopharyngeal carcinoma
Criteria
Inclusion Criteria:
- nasopharyngeal carcinoma patients treated in our institute between 2008-2018
Exclusion Criteria:
- missing clinical data
- 2nd Head and neck primary cancer
- very locally advanced or distant metastatic nasopharyngeal carcinoma
- Prior radiation therapy to the head and neck region
Contacts and Locations
Contacts
| Contact: Eran S Fridman, MD | +972-4-7772480 | eran.frid@gmail.com |
Locations
| Israel | |
| Rambam medical center | |
| Haifa, Israel | |
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
| Principal Investigator: | Eran S Fridman, MD | Rambam Health Care Campus |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 9, 2019 | ||||
| First Posted Date | July 10, 2019 | ||||
| Last Update Posted Date | July 10, 2019 | ||||
| Estimated Study Start Date | July 20, 2019 | ||||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Overall survival [ Time Frame: 6 months ] | ||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | The Prognostic Value of Human Papilloma Virus in Nasopharyngeal Carcinoma | ||||
| Official Title | The Prognostic Value of Human Papilloma Virus in Nasopharyngeal Carcinoma | ||||
| Brief Summary | It is well established that HPV infection has a casual and is a prognostic factor in several cancer types, including oropharynx. We wish to examine if HPV infection has a prognostic significance in nasopharyngeal carcinoma. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description:
Histopathological slides
|
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients diagnosed with nasopharyngeal carcinoma | ||||
| Condition | Nasopharyngeal Carcinoma | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Not yet recruiting | ||||
| Estimated Enrollment |
100 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 2020 | ||||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
|
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| Listed Location Countries | Israel | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04014738 | ||||
| Other Study ID Numbers | 0190-19-RMB-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Rambam Health Care Campus | ||||
| Study Sponsor | Rambam Health Care Campus | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | Rambam Health Care Campus | ||||
| Verification Date | July 2019 | ||||
