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Cardiac Biomarker Study in Esophageal Cancer Patients Treated With Chemotherapy and Radiation

25. juli 2014 opdateret af: M.D. Anderson Cancer Center

The goal of this clinical research study is to learn if the radiation that you will receive for esophageal cancer may cause the heart to create more proteins called cardiac biomarkers.

When cardiac biomarkers are above normal levels, there may be heart damage. The relationship between cardiac biomarkers and radiation therapy has not been well studied. Learning more about this relationship may lead to better ways to check the heart during radiation therapy and predict heart problems.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

If you are found to be eligible and you agree to take part in this study, you will have baseline tests. The following tests and procedures will be performed within 1-2 weeks from the start of radiation:

  • You will be asked about any other health problems you may have.
  • Your performance status will be recorded.
  • Blood (about 2 teaspoons) will be drawn for routine tests.
  • Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers.
  • You will have an electrocardiogram (ECG) to check your heart function.
  • If the study doctor thinks it is needed, you will have an exam by a cardiologist (a doctor who diagnoses and treats heart problems) who will check the results of your ECG.

Study Visits:

Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers at the following time points:

  • Within 12-24 hours of the start of radiation
  • One (1) time during the third week of radiation
  • Within 48 hours after completion of radiation

Follow-Up:

About 1 to 2 months after you complete radiation therapy, depending on when you and your doctor decide, you will return to the clinic. The following tests and procedures will be performed:

  • Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers.
  • You will have an ECG.

Length of Study Participation:

You will be off study after your follow-up visit.

You will no longer be able to take part in the study if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Using cardiac biomarkers to check the heart during radiation therapy to predict future heart problems is considered investigational.

Up to 100 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Undersøgelsestype

Observationel

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with histologically proven esophageal cancer to be treated with radiation therapy with concurrent chemotherapy to a final dose of >/=40 Gy included in this study at UT MD Anderson Cancer Center in Houston, Texas.

Beskrivelse

Inclusion Criteria:

  1. Patients with histologically proven esophageal cancer to be treated with RT with concurrent chemotherapy to a final dose of >/=40 Gy will be included in this study.
  2. Patients with mid thoracic, distal esophageal, and gastroesophageal junction tumors.
  3. All patients must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative.
  4. Age >/= 18
  5. Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]. For women of childbearing potential, a blood pregnancy test must be performed within 72 hours prior to the start of protocol treatment.
  6. Induction chemotherapy allowed.
  7. Being able to meet radiation dose constraints of at-risk organs.

Exclusion Criteria:

  1. Patients who receive cardiotoxic drugs, such as trastuzumab or adriamycin as part of their chemotherapy regimen.
  2. Patients with recent myocardial infarction in the past month, decompensated heart failure or myocarditis/pericarditis in the past month.
  3. Patients with renal failure indicated by a glomerular filtration rate (GFR) < 30 mL/min/1.73sq.m.
  4. Patients in the intensive care unit (ICU).
  5. Patients with systemic sepsis.
  6. Patients with acute pulmonary embolism in the past month.
  7. Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child.
  8. Inability to obtain histologic proof of malignancy.
  9. Patients with proximal / cervical esophageal cancer.

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
Cardiac Biomarkers
Patients with histologically proven esophageal cancer to be treated with radiation therapy with concurrent chemotherapy to a final dose of >/=40 Gy included in this study at UT MD Anderson Cancer Center in Houston, Texas.
Andet: Cardiac Biomarker Blood Draws
Blood (about 1 teaspoon) drawn to measure cardiac biomarkers at the following time points: within 12-24 hours of the start of radiation, one (1) time during the third week of radiation, within 48 hours after completion of radiation, and about 1 to 2 months after completion of radiation therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of Cardiac Biomarker Elevation with Radiation Therapy
Tidsramme: Within 24 hours after first fraction of radiation therapy (RT), during 3rd week of RT (fraction 11-15), within 48 hours of RT completion (fraction 26-28).
Descriptive statistics used to summarize change from baseline in enzyme levels at each time point (beyond baseline). Each enzyme examined separately. Pearson or Spearman correlation coefficient used to examine correlation between changes in cardiac biomarkers from baseline in enzyme level at each time point and mean radiotherapy dose or cumulative dose to heart. Linear mixed effects regression model used to model longitudinal change in cardiac biomarker from baseline as a function of cumulative radiation to the heart, radiation modality (Protons vs Photons), and time.
Within 24 hours after first fraction of radiation therapy (RT), during 3rd week of RT (fraction 11-15), within 48 hours of RT completion (fraction 26-28).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Adverse Cardiac Outcomes
Tidsramme: Within 24 hours after first fraction of radiation therapy (RT), during 3rd week of RT (fraction 11-15), within 48 hours of RT completion (fraction 26-28).
Incidence of adverse cardiac outcomes tabulated including myocardial infarction, heart failure, arrhythmias, all-cause and cardiac-specific mortality at same time points used to analyze cardiac biomarker levels.
Within 24 hours after first fraction of radiation therapy (RT), during 3rd week of RT (fraction 11-15), within 48 hours of RT completion (fraction 26-28).

Samarbejdspartnere og efterforskere

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

Sponsor

M.D. Anderson Cancer Center

Efterforskere

  • Ledende efterforsker: Steven H. Lin, MD,PHD, UT MD Anderson 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.

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. april 2014

Primær færdiggørelse (Forventet)

1. april 2024

Datoer for studieregistrering

Først indsendt

21. juni 2012

Først indsendt, der opfyldte QC-kriterier

21. juni 2012

Først opslået (Skøn)

25. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juli 2014

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2012-0004

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 .

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Betingelser

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Kosttilskud

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Placeringer

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