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RecruitingNCT01137825Updated Jun 29, 2026

Registry of Older Patients With Cancer

An observational study in Chronic Myeloproliferative Disorders, Cognitive/Functional Effects and Leukemia, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
3,000
Ages
65 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Myeloproliferative Disorders
  • Cognitive/Functional Effects
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Unspecified Adult Solid Tumor, Protocol Specific

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
  • recurrent adult acute myeloid leukemia
  • recurrent adult T-cell leukemia/lymphoma
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • stage 0 chronic lymphocytic leukemia
  • stage I adult T-cell leukemia/lymphoma
  • stage I chronic lymphocytic leukemia
  • stage II adult T-cell leukemia/lymphoma
  • stage II chronic lymphocytic leukemia
  • stage III adult T-cell leukemia/lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV adult T-cell leukemia/lymphoma
  • stage IV chronic lymphocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • untreated hairy cell leukemia
  • recurrent adult Hodgkin lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • cutaneous B-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • adult grade III lymphomatoid granulomatosis
  • adult nasal type extranodal NK/T-cell lymphoma
  • Waldenstrom macroglobulinemia
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • stage I adult Burkitt lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I mantle cell lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • intraocular lymphoma
  • post-transplant lymphoproliferative disorder
  • chronic eosinophilic leukemia
  • chronic neutrophilic leukemia
  • primary myelofibrosis
  • essential thrombocythemia
  • polycythemia vera
  • extramedullary plasmacytoma
  • isolated plasmacytoma of bone
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • primary systemic amyloidosis
  • refractory multiple myeloma
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
03

In context

Myeloproliferative Disorders

667 studies on the registry are indexed under Myeloproliferative Disorders; 110 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 150 across 115 observational studies indexed under Myeloproliferative Disorders.

Browse Myeloproliferative Disorders studies →

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Oncology Patients or those with a presumed cancer diagnosis

Eligibility criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
06

What researchers measure

Primary outcomes

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

    Time frame: 4 years

  2. Completion of the Geriatric Assessment (GA)

    Time frame: Upon subject's first visit to the clinic

Secondary outcomes

  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

    Time frame: 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;

    Time frame: 2 years

07

Study locations

7 of 7 sites recruiting
  • Seby B. Jones Cancer Center
    Boone, North Carolina 28607, United States
    Recruiting
    • Marjorie Hrozencik, RN, BSN, OCN, CCRP · Contactmhrozencik@apprhs.org
    • Anna Sobol, MD · Principal investigator
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    Chapel Hill, North Carolina 27599-7295, United States
    Recruiting
    • Amy L Garrett, MA, CCRC · Contactamy_garrett@med.unc.edu · 919-966-0695
    • Hyman B. Muss, MD · Principal investigator
  • East Carolina University
    Greenville, North Carolina 27834, United States
    Recruiting
    • Tiffanie Moore, MPH · ContactMOORETI15@ecu.edu
    • Rachel Raab, MD · Principal investigator
  • Pardee Cancer Center
    Hendersonville, North Carolina 28739, United States
    Recruiting
  • Carteret Health Care Cancer Center
    Morehead City, North Carolina 28557, United States
    Recruiting
  • Carolina East Radiology
    New Bern, North Carolina 28560, United States
    Recruiting
  • Rex Healthcare
    Raleigh, North Carolina 27607, United States
    Recruiting
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01137825
Responsible party
Sponsor
First posted
Jun 4, 2010
Start date
Sep 2009
Primary completion
Jul 1, 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Jun 29, 2026

Study contacts

Kirsten A Nyrop, PhD
Contact
knyrop@med.unc.edu
(919) 962-5139
Hyman Muss, MD
principal investigator · UNC Lineberger Comprehensive Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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