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Colorectal CancerNCT02328677

ColoCare Study - Colorectal Cancer Cohort

An observational study of Colorectal Cancer, run by University of Utah at 7 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

ColoCare is an international prospective cohort study of stage I-IV colorectal cancer patients (ICD-10 C18-C20). Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Colorectal Cancer
How many people
5,000 participants
Where
7 sitesin 2 countries
Study dates
Mar 2007to Oct 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: ColoCare is an international prospective cohort study of stage I-IV colorectal cancer patients (ICD-10 C18-C20). The ColoCare Consortium is a multicenter initiative of interdisciplinary research on CRC outcome and prognosis, and comprises patient recruitment at 6 sites. Patients are recruited at baseline (time of first diagnosis, time prior to surgery or during treatment (FHCRC and HCI)) and followed for up to 10 years at regular timepoints (3m, 6m, 12m, 24m, 36m, 48m, 60m). The cohort includes a comprehensive collection of biospecimens and data.

Who may be able to join

  • Age 18-89 years; for patients recruited after 09/01/2021 the age range is 18-69 years. Recruitment of patients 70 years and older was maintained for specific sub-studies and re-initiated for specific R01 grant funding in ~06/2024
  • Men and women
  • Newly-diagnosed colon or rectal cancer (stages I-IV); CRC in treatment (FHCRC and HCI)
  • English (FHCRC, Moffitt, HCI, Cedars-Sinai, WashU St. Louis) or German (University Hospital Heidelberg)-speaking;
  • mentally/physically able to consent and participate.

Who cannot join

  • if one of the above in not fulfilled
  • insufficient language or consent capacity

Trial locations and contacts

7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Cornelia Ulrich, MS, PhD contact

(801) 213-5716

neli.ulrich@hci.utah.edu

Sheetal Hardikar, PhD contact

sheetal.hardikar@hci.utah.edu

7 sites in 2 countries

United States6 sites, 6 recruiting

  • University of Tennessee

    Knoxville, Tennessee, 37996

    David Shibata, MD, dshibata@uthsc.edu

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Jane Figueiredo, PhD, janefigu@usc.edu

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Cornelia Ulrich, MS, PhD, neli.ulrich@hci.utah.edu

    Recruiting

  • FHCRC

    Seattle, Washington, 98109-1024

    Christopher Li, MD, PhD, cili@fhcrc.org

    William Grady, MD, PhD, wgrady@fhcrc.org

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63112

    Adetunji T Toriola, MD, PhD, a.toriola@wustl.edu

    Recruiting

  • Lee H. Moffitt Cancer Center

    Tampa, Florida, 12902

    Erin Siegel, PhD, Erin.siegel@moffitt.org

    Recruiting

Other trials in United States

Germany1 site, 1 recruiting

  • University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

    Biljana Gigic, PhD, Biljana.Gigic@med.uni-heidelberg.de

    Recruiting

Other trials in Germany

About this study

Official title: ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis

ColoCare is an international prospective cohort study of stage I-IV colorectal cancer patients (ICD-10 C18-C20).

Read the detailed description

The ColoCare Study 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 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).

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 sub-studies or in studies for older cancer patients. Recruitment of patients >70 years was re-initiated after 06/2024 in anticipation of R01 grant funding.

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 (early-onset 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.

Keywords
Colorectal cancer, rectosigmoid, rectum, colon
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02328677
Study groupRoleWhat they receive
ColoCare FHCCActive patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2023: n=741
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, 2023: n=1,043
University Hospital HeidelbergActive patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2023: n=773
ColoCare Huntsman Cancer InstituteActive patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2023: n=514
Cedars-Sinai Medical CenterActive patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2023: n=291
Washington University School of Medicine in St. LouisActive patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2023: n=278
University of TennesseeActive patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2023: n=253

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free and overall survival

    Measured: up to 10 years

  2. Recurrence

    Measured: up to 5 years

Secondary outcomes (2)

  1. Health-related quality of life

    Measured: at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment

  2. Treatment toxicities

    Measured: up to 5 years post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2014 (estimated)
  2. Study startMar 2007
  3. Primary completionOct 2030 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02328677
Sponsor's protocol ID
6407
Status last verified
Jun 2025
First submitted
17 Nov 2014
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Himbert C, Delphan M, Scherer D, Bowers LW, Hursting S, Ulrich CM. Signals from the Adipose Microenvironment and the Obesity-Cancer Link-A Systematic Review. Cancer Prev Res (Phila). 2017 Sep;10(9):494-506. doi: 10.1158/1940-6207.CAPR-16-0322.

    PubMed 28864539

  • Ulrich CM, Himbert C, Holowatyj AN, Hursting SD. Energy balance and gastrointestinal cancer: risk, interventions, outcomes and mechanisms. Nat Rev Gastroenterol Hepatol. 2018 Nov;15(11):683-698. doi: 10.1038/s41575-018-0053-2.

    PubMed 30158569

  • Zhang P, Holowatyj AN, Roy T, Pronovost SM, Marchetti M, Liu H, Ulrich CM, Edgar BA. An SH3PX1-Dependent Endocytosis-Autophagy Network Restrains Intestinal Stem Cell Proliferation by Counteracting EGFR-ERK Signaling. Dev Cell. 2019 May 20;49(4):574-589.e5. doi: 10.1016/j.devcel.2019.03.029. Epub 2019 Apr 18.

    PubMed 31006650

  • Yu B, Zanetti KA, Temprosa M, Albanes D, Appel N, Barrera CB, Ben-Shlomo Y, Boerwinkle E, Casas JP, Clish C, Dale C, Dehghan A, Derkach A, Eliassen AH, Elliott P, Fahy E, Gieger C, Gunter MJ, Harada S, Harris T, Herr DR, Herrington D, Hirschhorn JN, Hoover E, Hsing AW, Johansson M, Kelly RS, Khoo CM, Kivimaki M, Kristal BS, Langenberg C, Lasky-Su J, Lawlor DA, Lotta LA, Mangino M, Le Marchand L, Mathe E, Matthews CE, Menni C, Mucci LA, Murphy R, Oresic M, Orwoll E, Ose J, Pereira AC, Playdon MC, Poston L, Price J, Qi Q, Rexrode K, Risch A, Sampson J, Seow WJ, Sesso HD, Shah SH, Shu XO, Smith GCS, Sovio U, Stevens VL, Stolzenberg-Solomon R, Takebayashi T, Tillin T, Travis R, Tzoulaki I, Ulrich CM, Vasan RS, Verma M, Wang Y, Wareham NJ, Wong A, Younes N, Zhao H, Zheng W, Moore SC. The Consortium of Metabolomics Studies (COMETS): Metabolomics in 47 Prospective Cohort Studies. Am J Epidemiol. 2019 Jun 1;188(6):991-1012. doi: 10.1093/aje/kwz028.

    PubMed 31155658

  • Playdon MC, Joshi AD, Tabung FK, Cheng S, Henglin M, Kim A, Lin T, van Roekel EH, Huang J, Krumsiek J, Wang Y, Mathe E, Temprosa M, Moore S, Chawes B, Eliassen AH, Gsur A, Gunter MJ, Harada S, Langenberg C, Oresic M, Perng W, Seow WJ, Zeleznik OA. Metabolomics Analytics Workflow for Epidemiological Research: Perspectives from the Consortium of Metabolomics Studies (COMETS). Metabolites. 2019 Jul 17;9(7):145. doi: 10.3390/metabo9070145.

    PubMed 31319517

  • Holowatyj AN, Lewis MA, Pannier ST, Kirchhoff AC, Hardikar S, Figueiredo JC, Huang LC, Shibata D, Schmit SL, Ulrich CM. Clinicopathologic and Racial/Ethnic Differences of Colorectal Cancer Among Adolescents and Young Adults. Clin Transl Gastroenterol. 2019 Jul;10(7):e00059. doi: 10.14309/ctg.0000000000000059.

    PubMed 31259751

  • Zhang P, Holowatyj AN, Ulrich CM, Edgar BA. Tumor suppressive autophagy in intestinal stem cells controls gut homeostasis. Autophagy. 2019 Sep;15(9):1668-1670. doi: 10.1080/15548627.2019.1633863. Epub 2019 Jun 20.

    PubMed 31213134

  • Simon LH, Saviers-Steiger C, Dunston ER, Galyean P, Kimball ER, Mendez J, Zickmund SL, Hansen PA, Ulrich CM, LaStayo PC, Steinberg D, Noren CS, Finch A, Seckinger L, Braun E, Chipman J, Brownson KE, Oza S, Coletta AM. Feasibility and acceptability of the Comprehensive Oncology Rehabilitation and Exercise (CORE) clinical workflow algorithm in patients with newly diagnosed stage I-III breast cancer who undergo surgery as first-line treatment. Cancer. 2025 May 1;131(9):e35798. doi: 10.1002/cncr.35798.

    PubMed 40289623

  • Ulrich CM, Himbert C, Barnes CA, Boucher KM, Daniels B, Bandera VM, Ligibel JA, Wetter DW, Hess R, Kim J, Lundberg K, Mitzman B, Marcus R, Finlayson SRG, LaStayo PC, Varghese TK Jr. Precision Exercise Effect on Fatigue and Function in Lung Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 May 1;160(5):495-519. doi: 10.1001/jamasurg.2025.0130.

    PubMed 40072448

  • Saez-Clarke E, Otto AK, Prinsloo S, Natori A, Wagner RW, Gomez TI, Ochoa JM, Tworoger SS, Ulrich CM, Hathaway CA, Peoples AR, Antoni MH, Bower JE, Cohen L, Penedo FJ. Development and initial psychometric evaluation of a COVID-related psychosocial experiences questionnaire for cancer survivors. Qual Life Res. 2023 Dec;32(12):3475-3494. doi: 10.1007/s11136-023-03456-4. Epub 2023 Jun 26.

    PubMed 37358738

  • Watts EL, Gonzales TI, Strain T, Saint-Maurice PF, Bishop DT, Chanock SJ, Johansson M, Keku TO, Le Marchand L, Moreno V, Newcomb PA, Newton CC, Pai RK, Purdue MP, Ulrich CM, Smith-Byrne K, Van Guelpen B; PRACTICAL consortium, CRUK, BPC3, CAPS, PEGASUS; Day FR, Wijndaele K, Wareham NJ, Matthews CE, Moore SC, Brage S. Observational and genetic associations between cardiorespiratory fitness and cancer: a UK Biobank and international consortia study. Br J Cancer. 2024 Jan;130(1):114-124. doi: 10.1038/s41416-023-02489-3. Epub 2023 Dec 6.

    PubMed 38057395

  • Siegel EM, Ulrich CM, Shibata D. Risk Stratification for Early-onset Colorectal Cancer Screening: Are We Ready for Implementation? Cancer Prev Res (Phila). 2023 Sep 1;16(9):479-481. doi: 10.1158/1940-6207.CAPR-23-0239.

    PubMed 37655450

  • Hiensch AE, Beckhaus J, Witlox L, Monninkhof EM, Schagen SB, van Vulpen JK, Sweegers MG, Newton RU, Aaronson NK, Galvao DA, Steindorf K, Stuiver MM, Mesters I, Knoop H, Goedendorp MM, Bohus M, Thorsen L, Schulz KH, Schmidt ME, Ulrich CM, Sonke GS, van Harten WH, Winters-Stone KM, Velthuis MJ, Taaffe DR, van Mechelen W, Kersten MJ, Nollet F, Wiskemann J, Buffart LM, May AM. Moderators of exercise effects on self-reported cognitive functioning in cancer survivors: an individual participant data meta-analysis. J Cancer Surviv. 2024 Oct;18(5):1492-1503. doi: 10.1007/s11764-023-01392-3. Epub 2023 May 9.

    PubMed 37160571

  • Jin N, Hoyd R, Yilmaz AS, Zhu J, Liu Y, Singh MJ, Grencewicz D, Mo X, Kalady M, Rosenberg D, Dravillas CE, Singer EA, Carpten JD, Chan CH, Churchman ML, Denko NC, Di Clemente F, Dodd RD, Eljilany I, Fei N, Hardikar S, Ikeguchi AP, Ma A, Ma Q, McCarter MD, Osman AE, Riedlinger G, Robinson LA, Schneider BP, Tarhini AA, Tinoco G, Figueiredo J, Zakharia Y, Ulrich CM, Tan AC, Spakowicz D. Epigenetic Modulation, Intra-tumoral Microbiome and Immunity in Early Onset Colorectal Cancer. bioRxiv [Preprint]. 2025 Apr 2:2025.03.28.645992. doi: 10.1101/2025.03.28.645992.

    PubMed 40236026

  • Holthuijsen DDB, Rijnhart JJM, Bours MJL, van Roekel EH, Ueland PM, Breukink SO, Janssen-Heijnen MLG, Konsten JL, Keulen ETP, McCann A, Brezina S, Gigic B, Ulrich CM, Weijenberg MP, Eussen SJPM. Longitudinal associations of dietary intake with fatigue in colorectal cancer survivors up to 1 year post-treatment, and the potential mediating role of the kynurenine pathway. Brain Behav Immun. 2025 May;126:144-159. doi: 10.1016/j.bbi.2025.02.003. Epub 2025 Feb 7.

    PubMed 39922470

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by University of Utah at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cornelia Ulrich, MS, PhD ((801) 213-5716, neli.ulrich@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free and overall survival (time frame: up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02328677, which also lists 191 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.

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