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临床试验/NCT06678919
NCT06678919招募中不适用

AGMT Metastatic Colorectal Cancer Registry (mCRC) Third Line and Beyond

Arbeitsgemeinschaft medikamentoese Tumortherapie7 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
7
主要终点
Overall Survival

研究概览

简要总结

Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States and Europe. Although selected patients with oligometastatic CRC undergo systemic therapy and surgery/local ablative therapy in curative intent, the treatment approach for the majority of metastatic CRC (mCRC) patients remains palliative with a median overall survival (OS) ranging between 9-38 months depending on various prognostic and predictive factors. Particularly in advanced stages (in the third line of therapy and beyond), interesting and promising results have recently been achieved with various treatment approaches. The aim of this registry is to establish a disease-specific registry to evaluate the treatment landscape of patients with mCRC who have already received at least two lines of therapy.

详细描述

This registry aims at retrospectively and prospectively evaluating the treatment landscape and clinical outcome of mCRC ≥3L in a collective attempt by including multiple oncologic centers in Austria.

Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. Imaging studies ≥3L will be centrally collected in a virtual "imaging-bank" and tumor tissue samples of deceased patients will be stored in a central "bio-bank". Additionally, further biomaterial (e.g. ctDNA samples or DNA from DPYD genotyping) may be requested from the centres in case of specific research questions. The patient follow-up data will be obtained until patient death or loss to follow-up.

For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which have already been recorded in the patients' medical charts, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patients' medical and other registry information throughout the lifetime of the registry.

A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.

Data will be collected from all sites willing to participate.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients ≥ 18 years with tissue-based diagnosis of mCRC
  • ≥ 2 prior lines of palliative systemic therapy including 5-FU, irinotecan, oxaliplatin, anti-VEGF, anti-EGFR (in case of RAS/BRAF wildtype), anti-PD1- therapy (in case of MSI/MMRd) . (Exception: Patients who have received mFOLFOXIRI +/- anti-VEGF or anti- EGFR- 1L therapy or patients with ineligibility to receive 5-FU, oxaliplatin or irinotecan can be included after 1st line.)

排除标准

  • Due to the non-interventional design of this registry, there are no specific exclusion criteria

结局指标

主要结局

Overall Survival

时间窗: 10 years

Overall survival with the respective treatment protocols ≥3L

Progression free survival

时间窗: 10 years

Progression-free survival (PFS) with the respective treatments protocols ≥3L

Overall response rate (ORR)

时间窗: 10 years

Overall response rate (ORR) with the respective ≥3L treatment protocols

Blinded Independent Central Review (BICR)

时间窗: 10 years

Blinded Independent Central Review (BICR) based on the virtual imaging-bank

Identification of predictive biomarkers

时间窗: 10 years

Identification of predictive biomarkers for mCRC patient sub-cohorts of interest based on the centrally-located bio-bank

次要结局

未报告次要终点

研究者

发起方
Arbeitsgemeinschaft medikamentoese Tumortherapie
申办方类型
Other
责任方
Sponsor

研究点 (7)

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