Prospective Data Collection Initiative on Colorectal Cancer (PLCRC)

• ClinicalTrials.gov Identifier: NCT02070146
• Recruitment Status: Recruiting
• First Posted: February 25, 2014
• Last Update Posted: January 15, 2019
• Sponsor: Dutch Colorectal Cancer Group
• Information provided by (Responsible Party): Dutch Colorectal Cancer Group

Study Description

Brief Summary:

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.

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 for CRC 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.

Condition or disease
Colorectal Cancer

Detailed Description:

Objectives

• To start a prospective observational cohort study of CRC patients from their primary diagnosis until death.
• After obtaining Informed Consent, to prospectively collect data on medical history, serious comorbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and grade 3/4 adverse events.
• After obtaining separate Informed Consent for biobanking, to store blood and tumor tissue material, obtained during routine practice, in the biobank.
• The cohort will serve as an infrastructure geared towards efficient, safe and comprehensive clinical evaluation of new (image guided) interventions for treatment of CRC.

Expected outcome

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

A. Prognostic research B. Biological research and (epi)genetic research C. Studies that compare new therapies in a target population according to the cohort multiple randomized controlled trial design. D. Health care policies and cost-effectiveness studies

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 50 Years
• Official Title: Prospective Data Collection Initiative on Colorectal Cancer - a Prospective Observational Cohort Study -
• Study Start Date: May 2013
• Estimated Primary Completion Date: January 2050
• Estimated Study Completion Date: January 2051

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Progression free survival [ Time Frame: up to 10 years ]

Secondary Outcome Measures :

1. Health related quality of life [ Time Frame: 3, 6, 12, 24, 36, 48 months ]
   measured by EORTC QLQ questionnaire
2. Grade 3/4 (serious) adverse events [ Time Frame: 3 months ]
3. Disease free survival [ Time Frame: up to 10 years ]
4. Overall survival [ Time Frame: up to 10 years ]
5. Work Ability Index (WAI) [ Time Frame: 3, 6, 12, 24, 36, 48 months ]

Biospecimen Retention:   Samples With DNA

Blood and tumor tissue will be stored.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with CRC who are treated in one of the participating hospitals will be asked to participate in this cohort study.

Criteria

Inclusion Criteria:

• Age ≥ 18 years
• Histological proof of CRC
• New diagnosis of CRC and/or currently being treated for CRC

Exclusion Criteria:

• None. Participation of patients to the PLCRC project does not exclude participation in any other ongoing or future study.

Contacts and Locations

Contacts

Contact: Miriam Koopman, MD, PhD; m.koopman-6@umcutrecht.nl

  Show 53 Study Locations

Sponsors and Collaborators

Dutch Colorectal Cancer Group

Investigators

• Principal Investigator: Miriam Koopman, MD, PhD; UMC Utrecht
• Principal Investigator: Lenny HM Verkooijen, MD, PhD; UMC Utrecht
• Principal Investigator: Martijn GH van Oijen, PhD; AIDS Malignancy Consortium
• Principal Investigator: Peter D Siersema, MD, PhD; Radboud University

More Information

Additional Information:

• Responsible Party: Dutch Colorectal Cancer Group
• ClinicalTrials.gov Identifier: NCT02070146 History of Changes
• Other Study ID Numbers: 12-510
• First Posted: February 25, 2014
• Last Update Posted: January 15, 2019
• Last Verified: January 2019

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases