Monocentric Retrospective and Prospective Observational Study of Patients With Colorectal Cancer

Обзор

Monocentric retrospective and prospective observational study of patients with colorectal cancer

Подробное описание

Monocentric retrospective and prospective observational study of patients with colorectal cancer The study aims to collect all data (pathological, radiological, surgical, molecular, therapeutics, stage of disease, patients' age, laboratory exams) of patients with colorectal neoplasm, at any stage and accessing to IRCCS Ospedale San Raffaele, with the purpose to analyse patients' outcomes and relating them with the above mentioned features. Moreover, biological samples will be collected at different clinically relevant endpoints to seek potential biomarker useful to a better management of CRC.

Additional biological samples (blood volume collection, approximately 30 mL) will be collected before, during and after treatment at specific timepoints, such as baseline, at disease progression and pre- and post-surgery when applicable.

For the retrospective cohort patients with colorectal cancer accessing to IRCCS Ospedale San Raffaele from 2020 to the data of protocol approval will be included (approx. 500 patients). For the prospective cohort approximately 1500 patients will be included.

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years]
• Progression-Free Survival (PFS) [Срок оценки: From date of start of each treatment line until the date of first documented progression or date of death from any cause, assessed up to 12 months. Tumor assessments will be performed in accordance with clinical practice.]
• Disease-free survival (DFS) [Срок оценки: From date of surgery or complete response until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 5 years. Tumor assessments will be performed in accordance with clinical practice]
• R0 - Resection Rate [Срок оценки: At the time of surgery, based on postoperative pathological assessment]
• Incidence of Treatment-Related Adverse Events [Срок оценки: From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years]

Вторичные конечные точки (3)

• Incidence of Hospitalization [Срок оценки: From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years]
• Mean Change from Baseline in Laboratory Parameters [Срок оценки: From treatment initiation, during routine laboratory examination (every month as per clinical practice) and at disease progression until the date of death from any cause or last follow up, assessed up to 5 years]
• Patient-Reported Outcomes [Срок оценки: At baseline and during scheduled visits as per clinical practice until the date of death from any cause or last follow up, assessed up to 5 years.]

Критерии участия

Критерии включения

• Participant is willing and able to give informed and written consent for the participation in the study
• Patients affected by colorectal neoplasm (regardless of disease stage)
• Aged > 18 years
• Patients in clinical conditions permissive to adhere to the diagnostic-therapeutic program proposed in according to the stage of the disease

Критерии исключения

• Pediatric population
• Pre-existing conditions or concurrent diagnoses that would preclude the participant's full adherence with or completion of the study
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07663162 · CRC-R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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