Investigating the Tumour Immune Response of Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Feasibility of obtaining paired biopsy samples
研究概览
简要总结
This study aims to investigate immune changes which occur before and following standard radiotherapy in a range of tumour types. We will collect tissue and blood samples before and after radiation treatment from participants across six cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma and cutaneous squamous cell carcinoma/ basal cell carcinoma.
详细描述
The purpose of this prospective, non-CTIMP, translational study is to assess the feasibility of achieving paired biopsies for immune analysis in patients across six different cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma and cutaneous squamous cell carcinoma/ basal cell carcinoma.
All participants will have a minimum of 1 mandatory biopsy (during/post-radiotherapy [irradiated site]) and the potential to have a pre-treatment biopsy if the archival biopsy does not meet the suitability criteria.
Matched blood samples will be collected from participants at baseline, during/post-radiotherapy, and if radiotherapy continues after the on-treatment biopsy is taken, an additional end of treatment blood sample will be collected.
We aim to recruit 10-20 participants per study arm, with the option to increase numbers in study arms that are recruiting well - a maximum of 120 patients in total will be recruited to the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed cancer, Stage I-IV, in one of the following: Cervical, rectal, nodal Non-Hodgkin lymphoma, cutaneous lymphoma, Head & neck cancer
- •Diagnostic/pre-treatment biopsy confirmed suitable for translational research *
- •Performance status - ECOG 0-2 (Refer to appendix 1), ECOG 3 allowed for arm F (unrelated to underlying cancer) as this group of patients often have ECOG 3 due to age and comorbidities.
- •Age ≥ 18; no upper age limit.
- •Participant considered suitable for radiotherapy
- •Before participant registration, written informed consent must be given according to GCP and national regulations.
- •*Pre-treatment biopsy must be from the gross tumour volume within the planned radiation field and must also:
- •Have been formalin fixed for >12h and <72h
- •Have tumour tissue and morphology confirmed by H&E staining
- •Contain sufficient tumour cells (approximately 100)
排除标准
- •Participants deemed unsuitable for a biopsy (during or following radiotherapy) in the opinion of the treating oncologist.
- •Participants who have received chemotherapy within 28 days of starting radiotherapy.
- •Participants with intercurrent or past history of hepatitis B, C or human immunodeficiency virus infection if known. A negative test result for hepatitis B, C and HIV infection is required prior to inclusion in the study.
结局指标
主要结局
Feasibility of obtaining paired biopsy samples
时间窗: Within 6-7 weeks of starting radiotherapy
To assess the feasibility of obtaining tumour samples pre-radiotherapy (diagnostic or fresh) and a second biopsy during or immediately after radiotherapy, or a surgical sample, from patients undergoing standard of care RT.
Collection of matched blood samples
时间窗: Within 6-7 weeks of starting radiotherapy
To obtain additional matched blood samples pre-radiotherapy, during or post-radiotherapy, and at the end of radiotherapy for assessment of immune status of peripheral blood in comparison to the intratumoural microenvironment.
次要结局
未报告次要终点
研究者
Tim Illidge
Professor of Targeted Therapy and Oncology
University of Manchester