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NCT01958515 · ClinicalTrials.gov registry record
Immunologic Responses in HPV-Associated Carcinoma for Patients Receiving Chemoradiation
A clinical trial, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- 20
- Enrollment target
NCT01958515: Completed study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01958515 is a clinical trial that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01958515 has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
The primary purpose of this research is to investigate anti-tumor immune responses in patients undergoing chemotherapy and radiation for Head and Neck Cancers. Hypothesis: Treatment of HPV-associated OPSCC with concurrent chemoradiation results in changes in the tumor microenvironment. We hypothesize that these changes during daily fractionated chemoradiotherapy can lead to detectable changes in HPV-specific tumor immune responses. Hypothesis: HPV-specific cellular immune responses can still be detected during radiotherapy in the presence or absence of lymphopenia. * This study will determine whether specific anti-tumor immune responses (Specific Antibodies and Specific T-cells) can be detected in patients undergoing chemoradiation treatment for Head and Neck Cancers. * This study will evaluate the presence or absence of HPV (human papillomavirus) specific immune responses before, during, and after treatment for Head and Neck Cancers. * This study will also evaluate whether decreased white blood cell counts may affect development of immune responses in Head and Neck cancer patients undergoing treatment. Any head and neck cancer patient undergoing concurrent chemoradiotherapy is eligible if: you are older than 18 years of age, capable of providing informed consent, have a life expectancy of greater than 4 months, and have a good performance status. You are eligible irregardless of your HPV positive or negative status. People with HPV positive (human papillomavirus associated) head and neck cancer may join. People with HPV negative head and neck cancer may also join.
Primary Outcome
Primary objective: To evaluate the systemic and local immunologic changes which may occur during a standard treatment course of combined chemoradiation for HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) and non-HPV associated head and neck squamous cell carcinomas (HNSCC).
Interventions
- OTHER research blood draw and tissue biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-01-07 |
| Est. Completion | 2017-03-15 |
What the finished NCT01958515 record still lists
NCT01958515 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which research blood draw and tissue biopsy is the first listed.
NCT01958515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01958515 about?
NCT01958515 is a clinical study titled "Immunologic Responses in HPV-Associated Carcinoma for Patients Receiving Chemoradiation". The primary purpose of this research is to investigate anti-tumor immune responses in patients undergoing chemotherapy and radiation for Head and Neck Cancers. Hypothesis: Treatment of HPV-associated OPSCC with concurrent chemoradiation results in changes in the tumor microenvironment. We hypothesi...
What is the current status of trial NCT01958515?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2015-01-07. Estimated completion is 2017-03-15.
What interventions are being tested in trial NCT01958515?
The interventions under investigation include: research blood draw and tissue biopsy (OTHER).
Who is sponsoring clinical trial NCT01958515?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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