数字信息系统的临床试验-临床试验注册中心-ICH GCP

研究概览

地位

主动，不招人

条件

数字信息系统

详细说明

A prospective cohort study, conducted in Canada, to prospectively evaluate whether the combination of clinicopathological criteria and the Oncotype DX DCIS score can identify a group of women at very low risk of local recurrence following breast conserving surgery who do not require breast radiation therapy. We plan to screen 809 consenting women who will have their tumour tissue specimen sent to Exact Sciences to assess their DCIS score. We anticipate that 526 women will have an Oncotype DX DCIS score with a predicted 10-year risk of local recurrence ≤10%, these women will be enrolled and followed as part of the study.

At each centre, all patients with DCIS referred to radiation oncology will be documented. When a physician identifies an eligible patient, the patient will be approached by the referring physician or delegate to voluntarily provide informed consent to participate in this study. Consenting patients will be registered through the Ontario Clinical Oncology Group's (OCOG) web-based registration system. A two-step registration/enrollment process will be implemented.

Data related to the patient demographics, surgery details, tumour characteristics and ECOG performance will be collected. The patient's tumour specimen will be sent for analysis to Exact Sciences. The DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. Patients will be followed yearly up to 10 years. Bilateral mammograms and breast exams will be performed annually. The study data will be verified by source documentation.

研究类型

观察性的

注册 (估计的)

526

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

加拿大
- Alberta
  - Calgary、Alberta、加拿大、T2N 5G2
    - Arthur J.E. Child Comprehensive Cancer Centre
  - Edmonton、Alberta、加拿大、T6G 1Z2
    - Cross Cancer Institute
- British Columbia
  - Abbotsford British Columbia、British Columbia、加拿大、V2S 0C2
    - BC Cancer - Abbotsford Centre
  - Prince George、British Columbia、加拿大、V2M 7E9
    - BC Cancer - Centre for the North (Prince George)
  - Surrey、British Columbia、加拿大、V3V 1Z2
    - BC Cancer - Fraser Valley Centre
  - Vancouver、British Columbia、加拿大、V5Z 4E6
    - BC Cancer - Vancouver Centre
  - Victoria、British Columbia、加拿大、V8R 6V5
    - BC Cancer - Victoria
- Manitoba
  - Winnipeg、Manitoba、加拿大、R3E 0V9
    - CancerCare Manitoba
- Nova Scotia
  - Halifax、Nova Scotia、加拿大、B3H 1V7
    - QE II HSC - Nova Scotia Cancer Centre
  - Sydney、Nova Scotia、加拿大、B1P 1P3
    - Cape Breton Cancer Centre
- Ontario
  - Barrie、Ontario、加拿大、L4M 6M2
    - Royal Victoria Regional Health Centre
  - Hamilton、Ontario、加拿大、L8V 5C2
    - Juravinski Cancer Centre
  - London、Ontario、加拿大、N6A 4L6
    - London Regional Cancer Program
  - Thunder Bay、Ontario、加拿大、P7B 6V4
    - Regional Cancer Care, Thunder Bay Regional Health Sciences Centre
  - Toronto、Ontario、加拿大、M4N 3M5
    - Sunnybrook Health Science Centre -Odette Cancer Centre
  - Toronto、Ontario、加拿大、M5G 2M9
    - University Health Network - Princess Margaret Cancer Centre
  - Windsor、Ontario、加拿大、N8W 2X3
    - Windsor Regional Cancer Centre
- Quebec
  - Greenfield Park、Quebec、加拿大、J4V 2H1
    - Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre)
  - Montreal、Quebec、加拿大、H4A 3J1
    - McGill University Health Centre
  - Montreal、Quebec、加拿大、H2L 4M1
    - CHUM - Centre Hospitalier de L'Université de Montréal
  - Québec、Quebec、加拿大、G1J 1Z4
    - Centre intégré de cancérologie du CHU de Québec - Université Laval
  - Trois-Rivières、Quebec、加拿大、G8Z 3R9
    - Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières
- Saskatchewan
  - Regina、Saskatchewan、加拿大、S4T 7T1
    - Allan Blair Cancer Centre
  - Saskatoon、Saskatchewan、加拿大、S7N4H4
    - Saskatoon Cancer Centre

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

46年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

概率样本

研究人群

Prospective cohort study conducted in Canada in women with a low risk DCIS following breast conserving surgery who are candidates for radiation.

Eligibility status should be confirmed by the referring physician or delegate prior to enrollment. It is important that no exceptions are made to the eligibility criteria. Questions related to eligibility requirements and/or specific criteria should be addressed with OCOG prior to enrollment

描述

Inclusion Criteria:

Female patient > 45 years of age with DCIS without microinvasion.
Tumour size ≤ 2.5cm.
Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.*

* Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if the dissection was confirmed to be taken to skin and down to fascia with no DCIS present at inked margins.
Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.

Exclusion Criteria:

Multifocal DCIS.
History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.
Synchronous or previous invasive or non-invasive breast cancer.
Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.
ECOG performance status ≥3.
Life expectancy <10 years.
Geographic inaccessibility for follow-up.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：PROSPECTIVE

团体/队列数

1

队列和干预

团体/队列
Single Arm Cohort Evaluating the risk of Local Recurrence (LR) in a group of women postulated to be at low risk of LR following Breast Conserving Surgery alone defined by a combination of clinicopathological factors and Oncotype DX DCIS score.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Ipsilateral local recurrence (LR) 大体时间：5 Year	Defined as recurrent invasive or in situ cancer in the ipsilateral breast	5 Year

次要结果测量

结果测量	措施说明	大体时间
Ipsilateral invasive local recurrence 大体时间：5 Year	defined as time from study registration to time of recurrent invasive cancer in the ipsilateral breast	5 Year
Breast cancer recurrence-free interval (RFI) 大体时间：5 Year	defined as time from study registration to time of documented recurrent disease (ipsilateral breast (DCIS or invasive), regional, distant or death from breast cancer	5 Year
Distant disease-free survival (DDFS) 大体时间：5 Year	defined as time from study registration to distant recurrence	5 Year
Disease-free survival (DFS) 大体时间：5 Year	defined as time from registration to time of LR (DCIS or invasive), regional and distant recurrence, contralateral breast cancer, new primary (non-breast) and death from any cause	5 Year
Overall survival (OS) 大体时间：5 Year	defined as time from registration to death of any cause	5 Year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ontario Clinical Oncology Group (OCOG)

合作者

Canadian Institutes of Health Research (CIHR)

Hamilton Health Sciences Corporation

调查人员

首席研究员：Eileen Rakovitch, M.D.、Sunnybrook Research Institute, Sunnybrook Health Science
首席研究员：Tim Whelan, M.D、Juravinski Cancer Centre

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

<p>TRACE/OCOG website accessed by clinical centres</p>

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年11月23日

初级完成 (估计的)

2030年11月30日

研究完成 (估计的)

2035年11月30日

研究注册日期

首次提交

2021年3月10日

首先提交符合 QC 标准的

2021年3月10日

首次发布 (实际的)

2021年3月15日

研究记录更新

最后更新发布 (实际的)

2026年10月5日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年6月1日

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