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JOURNAL ONKOLOGIE – STUDIE

ColoCare Study - Colorectal Cancer Cohort

Rekrutierend

NCT-Nummer:
NCT02328677

Studienbeginn:
März 2007

Letztes Update:
26.05.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Colorectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Utah

Collaborator:
German Cancer Research Center, H. Lee Moffitt Cancer Center and Research Institute, Huntsman Cancer Institute, Cedars-Sinai Medical Center, Washington University School of Medicine, University of Tennessee,

Studienleiter

Cornelia M Ulrich, MS, PhD
Principal Investigator
Huntsman Cancer Institute
William Grady, MD, PhD
Principal Investigator
Fred Hutchinson Cancer Center
Martin Schneider, MD
Principal Investigator
University Hospital Heidelberg
Christopher Li, MD
Principal Investigator
Fred Hutchinson Cancer Center
Erin Siegel, PhD
Principal Investigator
Lee H. Moffitt Cancer Center
Jane Figueiredo, PhD
Principal Investigator
Cedars-Sinai Medical Center
David Shibata, MD
Principal Investigator
University of Tennesee
Adetunji T. Toriola, MD, PhD
Principal Investigator
Washington University School of Medicine

Kontakt

Studienlocations
(3 von 7)

Alle anzeigen

Studien-Informationen

Detailed Description:

The ColoCare Consortium is a multicenter initiative establishing an international cohort of

colorectal cancer (CRC) patients for interdisciplinary studies of CRC prognosis and outcomes

with sites at the Fred Hutchinson Cancer Research Center, Seattle (Washington, USA), H. Lee

Moffitt Cancer Center and Research Institute, Tampa (Florida, USA), the University Hospital

Heidelberg (Germany), the Huntsman Cancer Institute (Utah, USA), the Cedars-Senai Medical

Center (California, USA), University of Washington St. Louis (Missouri, USA), and University

of Tennessee (Tennessee, USA). Additional information is provided in the study design paper,

that has been published in 2019 (https://pubmed.ncbi.nlm.nih.gov/30523039/).

Aims: The ColoCare Study investigates clinical outcomes, including disease-free and overall

survival, predictors of cancer recurrence, survival, health-related quality-of-life and

treatment toxicities. In addition, cross-sectional analyses of biomarkers and/or health

behaviors are undertaken. Patients will be recruited if their age range is 18-89 years. For

patients recruited after 09/01/2021 the age range is between 18-69 years, except if they

participate in specific pilot studies.

Patients are recruited at baseline (time of first diagnosis) and followed for up to 5 years

at regular timepoints (3m, 6m, 12m, 24m, 36m, 48m, 60m). The cohort includes a comprehensive

collection of specimens and data. For the U01 renewal phase (start September 2021) we

specifically focus on the recruitment of minorities (young patients, African American

patients, Hispanic patients) and patients with rectal cancer. Furthermore, we will have an

overall focus on questionnaire assessment at baseline, 12, and 60 months and intensive

medical chart abstraction 24 months and 60. months after enrollment into the study.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Age 18-89 years; for patients recruited after 09/01/2021 the age range is 18-69 years

2. Men and women

3. Newly-diagnosed colon or rectal cancer (stages I-IV); CRC in treatment (FHCRC and HCI)

4. English (FHCRC, Moffitt, HCI, Cedars-Sinai, WashU St. Louis) or German (University

Hospital Heidelberg)-speaking;

5. mentally/physically able to consent and participate.

Exclusion Criteria:

- if one of the above in not fulfilled

- insufficient language or consent capacity

Studien-Rationale

Primary outcome:

1. Disease-free and overall survival (Time Frame - up to 10 years)

2. Recurrence (Time Frame - up to 5 years)

Secondary outcome:

1. Health-related quality of life (Time Frame - at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment)

2. Treatment toxicities (Time Frame - up to 5 years post treatment)

Studien-Arme

  • ColoCare FHCRC
    Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=679
  • ColoCare Moffitt (affiliated cohort)
    Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=895
  • University Hospital Heidelberg
    Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=721
  • ColoCare Huntsman Cancer Institute
    Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=394
  • Cedars-Sinai Medical Center
    Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=234
  • Washington University School of Medicine in St. Louis
    Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=232
  • University of Tennessee
    Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=183

Quelle: ClinicalTrials.gov


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