Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

NCT03935763 | Active Not Recruiting

• 2 other identifiers: DIM-95005-001EUPAS33865
• Study Type: observational
• Target: 738
• Locations: 18 countries
• Sites: 18

Brief Summary

A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

Conditions

Metastatic Colorectal Cancer

Keywords

Real Worl Evidence

Outcome Measures

Primary Outcomes (1)

• Overall survival

  metastatic Colorectal Cancer (mCRC) overall survival in real world setting

  From date of randomization until the date of death from any cause, assessed up to 24 months months

Secondary Outcomes (2)

• Disease control measured by overall response

  within 18 months from enrollment

• Quality of life using Patients Reported Outcomes

  within 18 months from enrollment

Interventions

observational disease study OTHER

observation of routine clinical practices in mCRC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population will be adults with mCRC who are eligible and willing to receive subsequent treatment, having had two prior progressions since diagnosis of first metastasis.

You may qualify if:

• Age ≥ 18
• Diagnosis of mCRC
• Having had two disease progressions since diagnosis of first metastasis that led to first systemic treatment.

You may not qualify if:

• Currently participating in an investigational clinical trial (thus it does not apply to observational cohort studies)
• Currently being treated for other cancer(s)
• Not having mental capacity and/or ability to participate in the study

Sponsors & Collaborators

• Servier Affaires Médicales: lead

Study Sites (18)

Instituto de Oncología Angel H. Roffo

Buenos Aires, Argentina

Location

Landeskrankenhaus-Universitaetsklinik

Salzburg, 5020, Austria

Location

Antwerp University Hospital

Edegem, Belgium

Location

Klinicki Bolnicki Centar (KBC) Zagreb

Zagreb, Croatia

Location

University Hospital in Hradec Kralove Clinic of Oncology and Radiotherapy

Hradec Králové, Czechia

Location

Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

Location

Klinikum Wolfsburg

Wolfsburg, Germany

Location

University Hospital Of Heraklion

Heraklion, Greece

Location

Del-Pesti Centrum Korhaz OHII, Szent Laszlo Korhaz Telephely

Budapest, Hungary

Location

The Adelaide & Meath Hospital-Dublin Incorporating The National Children's Hospital

Dublin, Ireland

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Centro Des Estudos Egas Moniz - Hospital Santa Maria

Lisbon, Portugal

Location

Institute Of Oncology Ljubljana

Ljubljana, Slovenia

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Vasteras Central Hospital

Västerås, Sweden

Location

UniversitaetsSpital Zuerich (University Hospital Zurich)

Zurich, Switzerland

Location

Cancer Research UK, Department of Medical Oncology-The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (2)

• Moss B, Goodall EA, Maravic Z, Marti F, Moss M, Rowley S, Sarrauste C, Wheatstone P. Real-world evidence research in metastatic colorectal cancer: raising awareness of the need for patient contributions. Future Oncol. 2023 Aug;19(26):1809-1821. doi: 10.2217/fon-2022-1253. Epub 2023 Jul 13.

  PMID: 37439564 DERIVED

• Koopman M, Pinto C, Bodoky G, Garcia-Carbonero R, Marti FM, Bachet JB. Rationale and design of the PROMETCO study: a real-world, prospective, longitudinal cohort on the continuum of care of metastatic colorectal cancer from a clinical and patient perspective. Future Oncol. 2022 Apr;18(11):1313-1320. doi: 10.2217/fon-2021-1333. Epub 2022 Jan 19.

  PMID: 35043682 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 2, 2019
• Study Start: March 8, 2019
• Primary Completion: April 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

BE (1); IE (1); NL (1); PT (1); FR (1); SE (1); AU (1); AR (1); HU (1); ES (1); GB (1); SL (1); GR (1); DE (1); CR (1); CZ (1); IT (1); CH (1)