- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01958515
Immunologic Responses in HPV-Associated Carcinoma for Patients Receiving Chemoradiation
Evaluation of Immunologic Responses in HPV-Associated Oropharyngeal Carcinoma Patients Receiving Chemoradiation Therapy
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.
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21287
- The Johns Hopkins SKCCC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- patients must have head and neck cancer and be receiving concurrent chemotherapy and radiation
- patients greater than or equal to 18 years of age
- patients must be capable of providing informed consent
- patients must have a life expectancy of greater than 4 months
- patients must have an adequate performance status
Exclusion Criteria:
- Patients must not have had surgery for their head and neck cancer
- Patients must not have a diagnosis of an immunosuppressant disease
- Patients must not have certain uncontrolled concurrent illnesses
- Patients must not a history of autoimmune disease
- Patients must not be pregnant, become pregnant or breast feeding
- Patients must not have a history of certain prior malignancies
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Chemoradiation with Research Samples
Standard of care chemoradiation therapy will be given as clinically indicated by the treating physicians.
4 research blood and tissue samples will be obtained.
One before treatment starts, 2 while treatments are being received and finally one after treatments are completed.
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research blood draw and tissue biopsy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Compare Systemic and Local Immunologic Changes During Chemoradiation
기간: Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion
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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).
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Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Relationship of Radiotherapy-Related Lymphopenia and Changes in Cellular Immunity During Chemoradiation
기간: Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion
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Secondary objective: To explore the relationship between radiotherapy-related lymphopenia and changes in cellular immunity during a course of chemoradiation for HPV-associated OPSCC.
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Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion
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공동 작업자 및 조사자
수사관
- 수석 연구원: Harry Quon, M.D., Johns Hopkins SKCCC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- J13158
- IRB00092006 (기타 식별자: JHMIRB)
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