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Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related Illness Following Total Body Irradiation and Stem Cell Transplant

3. december 2020 opdateret af: Memorial Sloan Kettering Cancer Center

Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related IllnessFollowing Total Body Irradiation and Stem Cell Transplant

The purpose of this study is to better understand why some women who survived cancer or a related illness later develop diabetes, problems with their cholesterol, or other problems that may lead to heart disease. Because these problems may be related to treatment with total body irradiation and a stem cell transplant, the investigators will compare the rates of obesity, cholesterol problems, and diabetes between women who were treated with total body irradiation and a stem cell transplant and women who were not.

The amount and location of fat stores in the abdomen is more important than overall weight or total body fat in the development of diabetes and cholesterol problems. In general, fat can be stored in several areas in the abdomen: around the organs (visceral fat), under the skin (subcutaneous fat), and in the liver (liver fat). People with higher amounts of fat around the organs (visceral fat), even those with a normal weight, are more likely to become diabetic or have high cholesterol. The amount of fat in each of these areas can be measured with an abdominal magnetic resonance imaging (MRI).

In this study, the investigators will use blood tests, height, weight, waist circumference, blood pressure measurements, and an abdominal MRI to evaluate for several risk factors of heart disease, including cholesterol problems, diabetes and pre-diabetes, elevated blood pressure, and increased abdominal fat.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

We will enroll 60 female participants in this study. From the population of interest, female cancer survivors (or women treated for a related illness) who were treated with TBI prior to a SCT, we will enroll 30 participants, 10 from each of the following cancer groups: acute lymphoblastic leukemia, acute myeloid leukemia, and chronic myeloid leukemia. We are interested in determining the outcomes in adult survivors who have completed their growth by the time of study and yet are younger than the age when most women generally begin to develop insulin resistance or dyslipidemia in the general population. For this reason, we will enroll women who are 18 - 49 years of age at the time of study.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

11

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 49 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Potential research subjects will be identified by a member of the research team from the SCT database and the medicine and pediatrics leukemia databases.

Beskrivelse

Inclusion Criteria:

Target population

  • Females 18 - 49 years of age at time of study
  • Previous diagnosis of ALL, AML, CML, CLL, Hodgkin's lymphoma, Non-hodgkin's lymphoma, aplastic anemia, and myelodysplastic syndrome
  • Previously treated with TBI (1200 - 1500 cGy) prior to SCT
  • Free of cancer
  • Two years or more from completion of cancer therapy
  • Able and willing to give informed consent

Comparison group

  • Females 18 - 49 years of age at time of study
  • Previous diagnosis of ALL, AML, CML CLL, Hodgkin's lymphoma, Non-hodgkin's lymphoma, aplastic anemia, and myelodysplastic syndrome
  • Free of cancer
  • Two years or more from completion of cancer therapy
  • Able and willing to give informed consent

Exclusion Criteria:

Target population

  • Pregnant at time of study
  • Previous cranial radiotherapy (other than TBI)
  • Second primary malignancy (other than non-melanoma skin cancer)
  • Any patient who has received glucocorticoids or tacrolimus within 60 days prior to the study
  • Currently on a medication for diabetes mellitus or dyslipidemia
  • Patients with a creatinine > 1.5 mg/dL or biopsy-proven chronic active hepatitis
  • Contraindication to an MRI

Comparison group

  • pregnant at time of study
  • Previous cranial radiotherapy
  • Second primary malignancy (other than non-melanoma skin cancer)
  • Any patient who has received glucocorticoids or tacrolimus within 60 days prior to the study
  • Currently on a medication for diabetes mellitus or dyslipidemia
  • Patients with a creatinine > 1.5 or biopsy-proven chronic active hepatitis
  • Contraindication to an MRI

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Women treated with SCT/TBI
Andet: Questionnaires, Laboratory tests, Abdominal MRI
Height, weight, waist and hip circumference; systolic and diastolic blood pressure; questionnaires; fasting blood tests: insulin, glucose, lipids (low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides, LDL pattern, HDL and LDL subspecies), cardiac inflammatory markers (hsCRP, IL-1B, IL-6, IL-10, TNFa), leptin, adiponectin, IGF-1, and IGFBP3; abdominal MRI for visceral and subcutaneous fat measurement
1:1 Matched group of women

Current age + or - 2 years

Race and ethnicity

Cancer diagnosis

Interval from completion of cancer therapy to study + or - 2 years
Andet: Questionnaires, Laboratory tests, Abdominal MRI
Height, weight, waist and hip circumference; systolic and diastolic blood pressure; questionnaires; fasting blood tests: insulin, glucose, lipids (low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides, LDL pattern, HDL and LDL subspecies), cardiac inflammatory markers (hsCRP, IL-1B, IL-6, IL-10, TNFa), leptin, adiponectin, IGF-1, and IGFBP3; abdominal MRI for visceral and subcutaneous fat measurement

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Explore whether visceral adipose tissue is significantly higher in women who were treated with total body irradiation (TBI) plus stem cell transplant in comparison with women who were not
Tidsramme: within 12 months
within 12 months

Sekundære resultatmål

Resultatmål
Tidsramme
Determine the differences in processes of changes, decisional balance for physical activity, body image, mood, and quality of life between the groups
Tidsramme: within 12 months
within 12 months
Determine the correlation between the amount of visceral adipose tissue and fasting levels of triglycerides, LDL, HDL, insulin, glucose, and HOMA-IR in both groups.
Tidsramme: within 12 months
within 12 months
To begin to characterize the psychosocial risk factors of the TBI plus stem cell transplant group, in relation to the comparison group, in order to inform a future targeted intervention to reduce risk.
Tidsramme: within 12 months
within 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Memorial Sloan Kettering Cancer Center

Samarbejdspartnere

Weill Medical College of Cornell University
Queen's University, Kingston, Ontario

Efterforskere

  • Ledende efterforsker: Kenneth Oeffinger, MD, Memorial Sloan Kettering Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2007

Primær færdiggørelse (Faktiske)

1. januar 2016

Studieafslutning (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først indsendt

31. juli 2007

Først indsendt, der opfyldte QC-kriterier

1. august 2007

Først opslået (Skøn)

2. august 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2020

Sidst verificeret

1. december 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 07-092

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Questionnaires, Laboratory tests, Abdominal MRI

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Sponsorer og samarbejdspartnere

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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