Prospective Data Collection Initiative on Colorectal Cancer

Официальное название

Prospective Data Collection Initiative on Colorectal Cancer - a Prospective Observational Cohort Study -

Обзор

Survival after colorectal cancer (CRC) diagnosis strongly depends on local tumor extent, lymph node involvement and the presence of distant metastases. However, there remains great inter-patient variability regarding treatment outcome. A combination of biochemical factors, histopathological features, genomic profile, environmental factors and other clinical factors are likely to influence prognosis and treatment effect, independent from tumor stage, but it is still unclear which, how, and to what extent these factors can influence tumor recurrence and mortality in both early stage (I-III) and late stage (IV) CRC, small bowel cancer and anal cancer. Although the results from prospective clinical trials will remain the backbone of evidence based medicine, this concerns a highly selected patient population since the large majority (85%-95%) of cancer patients do not participate in clinical trials for various reasons. It is unlikely that trial participation will significantly improve in the near future. This fact has the following implications: 1) It is highly desirable to validate the results from trials in the general patient population. However, this is complicated by the fact that the documentation of patients treated in general practice (i.e. outside the scope of clinical trials) is largely insufficient to provide comparable patient cohorts in terms of prognostic characteristics and treatment parameters. 2) There is an increased availability of novel technologies that provide molecular markers with potential prognostic and/or predictive value. To test the clinical value of these markers large numbers of patients are required which greatly exceeds the number of patients who consent to participate in prospective clinical trials. 3) as a result of rapid technical developments, a range of new minimally invasive treatment options are entering the market. These interventions have the potential to be of great benefit for patients in terms of improved local control, higher probability of complete tumor removal, less damage to surrounding tissue, faster recovery and less short and long term side effects. Still, the interventions will have to prove their effectiveness, safety and superiority (or non-inferiority) to standard cancer treatments on a patient level. A prospective observational cohort study has the great opportunity to fill this gap.

Подробное описание

Objectives

* To start a prospective observational cohort study of CRC, small bowel and anal cancer patients from their primary diagnosis until death. * After obtaining Informed Consent, to prospectively collect data on medical history, comorbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and (S)AEs. * After obtaining separate Informed Consent for collecting data on health related quality of life and work ability, to collect data on patient reported outcome measures. * After obtaining separate Informed Consent, to collect blood, (tumor) tissue or other body material, obtained during routine practice, for observational studies or storage in the biobank. * The cohort will serve as an infrastructure geared towards efficient, safe and comprehensive clinical evaluation of new interventions for patients with CRC according to the Trials within Cohorts (TwiCs) design.

Expected outcome

* More accurate data on the treatment and clinical and patient reported outcomes of CRC, small bowel and anal cancer in daily practice. * A continuous infrastructure for a large variety of research purposes including:

A. Prognostic and predictive research. B. Molecular research and (epi)genetic research. C. Comparison of new interventions for patients with CRC, small bowel and anal cancer according to the Trials within Cohorts (TwiCs) design. D. Health care policies and cost-effectiveness studies.

Первичные конечные точки

• Progression free survival [Срок оценки: up to 10 years]

Вторичные конечные точки (5)

• Health related quality of life [Срок оценки: 3, 6, 12, 24, 36, 48 months]
• Grade 3/4 (serious) adverse events [Срок оценки: 3 months]
• Disease free survival [Срок оценки: up to 10 years]
• Overall survival [Срок оценки: up to 10 years]
• Work Ability Index (WAI) [Срок оценки: 3, 6, 12, 24, 36, 48 months]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Histological proof of colorectal, small bowel and anal cancer, or a strong suspicion after imaging.
• Informed consent for longitudinal observational data collection.

Критерии исключения

• Mentally incompetent patients.

Participation of patients to the PLCRC project does not exclude participation in any other ongoing or future study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 70 центров

• Jeroen Bosch Ziekenhuis — 's-Hertogenbosch
• Noordwest Ziekenhuisgroep — Alkmaar
• Flevoziekenhuis — Almere Stad
• Meander Medisch Centrum — Amersfoort
• Ziekenhuis Amstelland — Amstelveen
• Antoni van Leeuwenhoek — Amsterdam
• OLVG — Amsterdam
• VUmc — Amsterdam
• … и ещё 62 центра

Публикации

• Pennings AJ, Vink GR, van Kuijk S, Melenhorst J, Beets GL, May AM, Breukink SO. Quality of life and functional outcome of rectal cancer patients: A prospective cohort study. Colorectal Dis. 2024 Nov;26(11):1892-1902. doi: 10.1111/codi.17181. Epub 2024 Oct 2. PMID 39358881
• van Lanen AS, Kok DE, Wesselink E, Derksen JWG, May AM, Smit KC, Koopman M, de Wilt J, Kampman E, van Duijnhoven FJB; COLON and PLCRC studies. Associations between low- and high-fat dairy intake and recurrence risk in people with stage I-III colorectal cancer differ by sex and primary tumour location. Int J Cancer. 2024 Sep 1;155(5):828-838. doi: 10.1002/ijc.34959. Epub 2024 May 3. PMID 38700376
• Smit KC, Derksen JWG, Stellato RK, VAN Lanen AS, Wesselink E, Belt EJT, Balen MC, Coene PPLO, Dekker JWT, DE Groot JW, Haringhuizen AW, VAN Halteren HK, VAN Heek TT, Helgason HH, Hendriks MP, DE Hingh IHJT, Hoekstra R, Houtsma D, Janssen JJB, Kok N, Konsten JLM, Los M, Meijerink MR, Mekenkamp LJM, Peeters KCMJ, Polee MB, Rietbroek RC, Schiphorst AHW, Schrauwen RWM, Schreinemakers J, Sie MPS, Simke PMID 38079324

Идентификаторы

NCT: NCT02070146 · 12-510

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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