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Chronic Myeloproliferative DisordersNCT01137825

Registry of Older Patients With Cancer

An observational study of Chronic Myeloproliferative Disorders and Cognitive/Functional Effects, run by UNC Lineberger Comprehensive Cancer Center at 7 sites in United States.

Recruiting

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

Sites and contacts
Official record
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Trial summary

RATIONALE: Gathering information about older patients with cancer may help the study of cancer in the future. PURPOSE: This research study is gathering information from older patients with cancer into a registry. Read more about this study

Who is it for?
Ages 65 years and older
How many people
3,000 participants
Where
7 sitesUnited States
Study dates
Sep 2009to Dec 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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Oncology Patients or those with a presumed cancer diagnosis

DISEASE CHARACTERISTICS:

  • Patients must have an appointment at the North Carolina Cancer Hospital and agree to complete the Geriatric Assessment NOTE: Not all patients included in the registry will ultimately be diagnosed with cancer. Patients who complete a GA and are not diagnosed with cancer will remain in the database, but will be categorized into a separate group and will not have their medical records accessed.

PATIENT CHARACTERISTICS:

  • Able to read and speak English

PRIOR CONCURRENT THERAPY:

  • Not specified

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kirsten A Nyrop, PhD contact

(919) 962-5139

knyrop@med.unc.edu

7 sites in 1 country

United States7 sites, 7 recruiting

  • Seby B. Jones Cancer Center

    Boone, North Carolina, 28607

    Marjorie Hrozencik, RN, BSN, OCN, CCRP, mhrozencik@apprhs.org

    Anna Sobol, MD

    Recruiting

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

    Amy L Garrett, MA, CCRC, 919-966-0695, amy_garrett@med.unc.edu

    Hyman B. Muss, MD

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Tiffanie Moore, MPH, MOORETI15@ecu.edu

    Rachel Raab, MD

    Recruiting

  • Pardee Cancer Center

    Hendersonville, North Carolina, 28739

    Lynn Jones, lyn.jones@unchealth.unc.edu

    James Radford, MD

    Recruiting

  • Carteret Health Care Cancer Center

    Morehead City, North Carolina, 28557

    Joanna Pittman, jlpittman@ccgh.org

    James Loynes, MD

    Recruiting

  • Carolina East Radiology

    New Bern, North Carolina, 28560

    Lynn Jones, BSN, RN, OCN, ljones2@carolinaeasthealth.com

    Seth Miller, MD

    Recruiting

  • Rex Healthcare

    Raleigh, North Carolina, 27607

    Nancy Burns, RN, Nancy.Burns2@unchealth.unc.edu

    Oludamilola Olajide, MD

    Recruiting

Other trials in United States

About this study

Official title: Carolina Senior: UNC Registry for Older Cancer Patients

RATIONALE: Gathering information about older patients with cancer may help the study of cancer in the future.

PURPOSE: This research study is gathering information from older patients with cancer into a registry.

Read the detailed description

OBJECTIVES:

Primary

  • To create a registry (to be called "Carolina Senior") of older patients with an appointment at North Carolina Cancer Hospital.
  • To have these patients complete a Geriatric Assessment (GA).

Secondary

  • To measure the response rates of GAs of Carolina Senior patients and their satisfaction with a GA by measuring the percentage of patients contacted who consent to complete the GA; the percentage of patients able to complete the self-administered portion of the GA without assistance; the length of time necessary to complete the GA; the variance and number of missing items; the percentage of GAs that contain all 3 of the following items: Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and healthcare professional-rated Karnofsky performance status; and patient satisfaction with the questionnaire by identifying items that are distressing or too difficult to comprehend.
  • To gather information, including patterns of patient care, that would lend support for future research in the 'Carolina Senior' population who receive a confirmed diagnosis of cancer (except for nonmelanoma skin cancer, cervical carcinoma in situ without evidence of disease, or prostatic intraepithelial neoplasia without evidence of prostate cancer).

OUTLINE: Patients complete a geriatric assessment, a multi-dimensional inter-disciplinary patient evaluation that includes an evaluation of a patient's functional status (ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medication review, and nutritional status. Patients' medical records are also reviewed. Patients' health status at 1 year is incorporated into the registry.

Keywords
cognitive/functional effects, unspecified adult solid tumor, protocol specific, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), atypical chronic myeloid leukemia, BCR-ABL negative, blastic phase chronic myelogenous leukemia, chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, mast cell leukemia, meningeal chronic myelogenous leukemia, progressive hairy cell leukemia, initial treatment, prolymphocytic leukemia, recurrent adult acute lymphoblastic leukemia
Medical subject headings
Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases

What is being measured

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

  1. Creation of a registry of older patients within the University of North Carolina's healthcare system

    Measured: 4 years

  2. Completion of the Geriatric Assessment (GA)

    Measured: Upon subject's first visit to the clinic

Secondary outcomes (2)

  1. Information that would lend support for future research

    Including patterns of patient care, that would lend support for future research in the 'Carolina Senior' population who receive a confirmed diagnosis of cancer with the exception of:

    • Non-melanoma skin cancer
    • Cervical carcinoma in situ without evidence of disease
    • Prostatic intraepithelial neoplasia without evidence of prostate cancer

    Measured: 3 years

  2. Response rates of Geriatric Assessments of Carolina Senior patients and their satisfaction with the GA

    Done by measuring:

    • Percentage of patients contacted who consent to complete the GA;
    • The percentage of patients able to complete the self-administered portion of the geriatric assessment without assistance;
    • The length of time necessary to complete the geriatric assessment;
    • The variance and number of missing items;
    • The percentage of geriatric assessments that contain all three of the following items: Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and healthcare professional-rated Karnofsky performance status;

    Measured: 2 years

Timeline

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

  1. First posted4 Jun 2010 (estimated)
  2. Study startSep 2009
  3. Primary completion1 Jul 2030 (estimated)
  4. Study completionDec 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
Case only
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01137825
Sponsor's protocol ID
LCCC 0916
Other IDs
P30CA016086, CDR0000674085
Status last verified
Jun 2026
First submitted
3 Jun 2010
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No

Publications

  • Pergolotti M, Langer MM, Deal AM, Muss HB, Nyrop K, Williams G. Mental status evaluation in older adults with cancer: Development of the Mental Health Index-13. J Geriatr Oncol. 2019 Mar;10(2):241-245. doi: 10.1016/j.jgo.2018.08.009. Epub 2018 Sep 8.

    PubMed 30205939

  • Guerard EJ, Deal AM, Williams GR, Jolly TA, Nyrop KA, Muss HB. Falls in Older Adults With Cancer: Evaluation by Oncology Providers. J Oncol Pract. 2015 Nov;11(6):470-4. doi: 10.1200/JOP.2014.003517. Epub 2015 Jul 14.

    PubMed 26175532

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Myeloproliferative Disorders and Cognitive/Functional Effects, run by UNC Lineberger Comprehensive Cancer Center at 7 sites in United States.

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

Who may be eligible to take part?

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 29 Jun 2026. 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. 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 Kirsten A Nyrop, PhD ((919) 962-5139, knyrop@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Creation of a registry of older patients within the University of North Carolina's healthcare system (time frame: 4 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 NCT01137825, which also lists 2 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 29 Jun 2026.

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