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AQUA: Cardiac Management of Patients With Thalassemia Minor and Breast Cancer

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT05960214
Collaborator
(none)
26
Enrollment
1
Location
41.9
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This retrospective study aimed to evaluate the demographic characteristics, clinical conditions in term of physical examination findings), functional status, and laboratory results of patients with thalassemia minor (TM) and breast cancer (BC) in order to identify any differences between the group with BC only.

Available data as anticancer treatment, comorbidities, weight and height will be combined to report body mass index (BMI) in kg/m2, systolic and diastolic blood pressure, heart rate, ECG, transthoracic echocardiography, blood count, lipid panels, glucose, kidney function tests, (N terminal) NT-proBNP, troponins, handgrip assessments, functional status were extracted from patients files and hospital electronic archives.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Following data was extracted from files and hospital electronic records, and will be evaluated (at baseline, 3, 6, 9 and 12 months):

    1. Physical examination findings (as pretibial edema, jugular venous distension, lung rales),

    2. Clinically significant changes in cardiac function as determined by Left Ventricular Ejection Fraction (LVEF) measurements using transthoracic echocardiography,

    3. Any changes in (N terminal) NT-ProBNP and troponin,

    4. Any changes in manual handgrip measurements for both hands using hydraulic hand dynamometer,

    5. Applied medications,

    were extracted and will be evaluated.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    26 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Management of Patients With Thalassemia Minor and Breast Cancer at CardioOncology Outpatient Clinics: Age Quod Agis (AQUA)
    Actual Study Start Date :
    Jan 1, 2020
    Actual Primary Completion Date :
    Jun 22, 2023
    Actual Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    13 pts with BC+TM

    Patients diagnosed with breast cancer and thalassemia minor
    13 pts with BC

    Patients diagnosed with breast cancer for comparison.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of any rise in troponin [From enrollment to 12 months]

      Troponin results from baseline and at 3, 6 and 12 months of cancer treatment .

    2. Incidence of any rise in NT-ProBNP [From enrollment to 12 months]

      NT-ProBNP results from baseline and at 3, 6 and 12 months of cancer treatment .

    3. Incidence of any reduction in LV [From enrollment to 12 months]

      Echocardiographic measurements of Left ventricle (LV) ejection fraction from baseline and at 3, 6 and 12 months of cancer treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients with diagnosis of breast cancer, and thalassemia minor,

    2. 18 years old,

    3. Referred by oncologist for cardiac evaluation.

    4. Patients with available cardiac evaluations data at baseline and during breast cancer treatment

    Exclusion Criteria:

    1. Patients without diagnosis of breast cancer, and thalassemia minor,

    2. <18 years old,

    3. Patients without any cardiac evaluations at baseline, and during cancer treatment.

    4. Patients with history of any cardiotoxic treatment prior to enrolment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul Faculty of Medicine Fatih Istanbul Turkey 34093

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Principal Investigator: Cafer Zorkun, MD PhD, Istanbul University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cafer Zorkun, Associate Professor, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT05960214
    Other Study ID Numbers:
    • COEXIST-3
    First Posted:
    Jul 25, 2023
    Last Update Posted:
    Jul 25, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cafer Zorkun, Associate Professor, Istanbul University
    Cardiotoxicity
    Cancer treatment related cardiac dysfunctions
    Additional relevant MeSH terms:
    Breast Neoplasms
    Heart Diseases
    Thalassemia
    beta-Thalassemia

    Study Results

    No Results Posted as of Jul 25, 2023