跳至主要内容
临床试验/NCT07290972
NCT07290972招募中不适用

Compliance to Cervical Cancer Chemoradiation Guidelines: A Implementation Audit and Resource Assessment Initiative of National Cancer Grid of India

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 618 人开始时间: 2021年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
618
试验地点
1
主要终点
report on institutional compliance to National Cancer Grid cervical cancer guidelines for chemo-radiation.

研究概览

简要总结

This is a combination of retrospective and prospective observational study that will be performed across NCG and other participating centers to report compliance to chemoradiation for cervical cancer. This audit will include patients treated with standard of care treatment, in this case definitive or adjuvant radiation+/- concurrent chemotherapy will be included. Patients recruited in various institutions in prospective clinical trials will not be included. The participating centersthat agree to contribute data will include all registered cases over a 6-month period that have been diagnosed with cervical cancer wherein treatment is planned with radical dose radiation and/or concurrent chemotherapy. Centers that do not have retrospective data of the patients will contribute data of patients registered prospectively over 6 months. Furthermore, any cases referred to the institution for brachytherapy alone will also be included.

As a first step member institutions that participated in guideline development process or provide an agreement to guidelines adherence will be audited. The project will be submitted in institutional ethics committees with memorandum of understanding for anonymized data sharing.

Each of the co-investigators listed from contributing centers will be directly responsible for collecting data contribution and accuracy of data submitted.

Those centres which cannot or do not want to participate will be requested to provide data on only compliance outcomes to treatment for at least of 5 consecutively patients diagnosed with cervical cancer wherein treatment is planned with radical dose radiation and /or concurrent chemotherapy over a period of 6 months.

详细描述

Investigator intend to use electronic case record form (e-CRF) created using on line portal (google e-forms) wherein details of patients treated within the 6 month period will be captured. Google e-CRF will be available to all participating centres free of charge and has ease of access for filling details on both computer, tablets or mobile phone platforms. The e-form is user friendly and provides automated excel output and basic trends of responses and is ideal to be used across busy departments and low resource settings.

To maintain data security, no patient identifying information will be collected. Each institution will be provided an institution id and name identifiers will not be used. Similarly a code will be generated for each of the patient and details of that code will remain with the parent institution.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

性别
Female
接受健康志愿者

入选标准

  • The participating centers that agree to contribute data will include all registered cases over a 6 month period that have been diagnosed with histologically proven cervical cancer wherein either radical, adjuvant or palliative radiation with or without concurrent or systemic chemotherapy is planned.
  • Furthermore any cases referred to the institution for brachytherapy alone will also be included.

排除标准

  • 未提供

研究组 & 干预措施

Patients diagnosed with Cervical Cancer

Patients diagnosed with histologically proven cervical cancer wherein either radical, adjuvant or palliative radiation with or without concurrent or systemic chemotherapy planned.

干预措施: Not applicable- observational study (Other)

结局指标

主要结局

report on institutional compliance to National Cancer Grid cervical cancer guidelines for chemo-radiation.

时间窗: 3 Months

To report praportion of patients with No deviation, Major \& Minor Deviation and unacceptable deviation for chemoradiation guidlines.

次要结局

  • To report on factors impacting compliance to standard guidelines(3years)
  • To report adequacy of infrastructural and manpower requirements for optimal treatment of cervical cancer in NCG centres and corresponding state of origin(3 years)
  • To compute relative risk of suboptimal treatment for cervical cancer in reference to infrastructural and manpower deficits(3 years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Supriya Sastri (chopra)

Professor Dr Supriya Sastri

Tata Memorial Centre

研究点 (1)

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