Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

19. oktober 2021 opdateret af: State University of New York - Upstate Medical University

Some patients who undergo breast cancer treatment with lumpectomy followed by radiation therapy develop significant late skin and soft tissue changes, resulting in a poor cosmetic outcome. The goal of this study is to try to predict severe tissue reactions by using a combination of three of the latest blood tests, one of which we have developed ourselves.

Studieoversigt

Status

Afsluttet

Betingelser

Abnormiteter, Stråling-induceret

Detaljeret beskrivelse

Three tubes of blood will be drawn from each subject. Two members of the study team will also independently assess each subject for the degree to which various radiation-induced soft tissue changes are evident. Subjects will be put into three groups according to the severity of the soft tissue changes which are noted, and the results of the blood tests for members of each group will be analyzed to determine whether a correlation with cosmetic outcomes can be determined. If the results are promising, they will be studied further and used as the basis for future prospective clinical trials.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

Kontakter og lokationer

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

Studiesteder

Forenede Stater
- New York
  - Syracuse, New York, Forenede Stater, 13210
    - SUNY Upstate Medical University

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

48 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Potential study subjects will be drawn from patients with a history of treatment for breast cancer with lumpectomy followed by radiation therapy.

Beskrivelse

Inclusion Criteria:

Breast cancer treatment: lumpectomy followed by external beam XRT to breast
Age at the time of radiotherapy treatment: 45-65 years old
XRT dose to breast: >/= 4500 and </= 5200 cGy, fraction size 180 or 200 cGy
Dose distribution: no area receiving >/= 112% of prescribed dose
Follow-ups: patients must be >/= 2.5 years post-treatment

Exclusion Criteria:

Reconstructive surgery to involved breast

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject Tidsramme: at least 2.5 years following lumpectomy and radiation therapy	at least 2.5 years following lumpectomy and radiation therapy

Samarbejdspartnere og efterforskere

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

Sponsor

State University of New York - Upstate Medical University

Samarbejdspartnere

Carol M. Baldwin Breast Cancer Research Fund, Inc.

Efterforskere

Ledende efterforsker: Peter J Hahn, PhD, State University of New York - Upstate Medical University

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. august 2006

Primær færdiggørelse (Faktiske)

1. august 2012

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

1. april 2008

Først indsendt, der opfyldte QC-kriterier