- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00355316
A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients
keskiviikko 19. kesäkuuta 2013 päivittänyt: Washington University School of Medicine
Peripheral Blood Molecular Staging of Breast Cancer: A Prospective Cohort Study Designed to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Peripheral Blood of Stage IV Breast Cancer Patients
This study is designed to determine whether molecular detection of breast cancer cells in the peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of progression-free and overall survival.
Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment.
Multi-marker real-time RT-PCR analysis will be performed on peripheral blood specimens from 92 breast cancer patients and 120 healthy volunteers.
Peripheral blood specimens from breast cancer patients will be obtained at the time of study entry (prior to initiation of systemic therapy) and at serial time points during follow-up.
Subjects will be followed longitudinally until death, although the study has been powered so that the primary objective can be addressed after 12 months of follow-up.
Healthy volunteers will be asked to provide a blood sample at time of enrollment but will not be followed.
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
224
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Missouri
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St. Louis, Missouri, Yhdysvallat, 63110
- Washington University School of Medicine
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South Carolina
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Charleston, South Carolina, Yhdysvallat, 29425
- Medical University of South Carolina
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
16 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Nainen
Kuvaus
Inclusion Criteria:
Inclusion Criteria - Stage IV breast cancer patients
- Patient age must be > 21 years.
- Patient must have a tissue diagnosis of invasive breast cancer.
- Patient must have documented evidence of metastatic disease.
- Patient must have measurable lesions.
- Patients must be initiating systemic therapy. Patients receiving hormonal therapy, and/or chemotherapy alone or in combination with other therapies are eligible.
- Patient must have an ECOG performance status of 0, 1, or 2.
- Patient must be available for follow-up.
- Patient or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
- The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patients have been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).
Inclusion Criteria - Healthy volunteers
A volunteer will be eligible for inclusion in this study only if ALL of the following criteria apply:
- Volunteer age must be > 21 years.
- Volunteer or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
- Patients with benign breast disease are eligible for enrollment.
- The volunteer with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided both of the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patient has been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).
Exclusion Criteria:
Exclusion Criteria - Stage IV breast cancer patients
A patient will be ineligible for inclusion in this study if ANY of the following criteria apply:
- No documented metastatic disease.
- No measurable lesions.
- Bone only and/or brain metastasis.
- Patient is not initiating a new regimen of systemic therapy.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Perustiede
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Stage IV Breast Cancer
Blood draws at baseline before systemic therapy.
Blood draw then every 6 weeks for approximately 12 weeks.
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Muut: Healthy Volunteers
Baseline blood draw.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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The prevalence of breast cancer cells in the peripheral blood
Aikaikkuna: 1 year
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Specifically, it is predicted that 60% of subjects with Stage IV breast cancer will have evidence of breast cancer cells in the peripheral blood by multi-marker real-time RT-PCR analysis, and that these subjects will experience a significantly decreased progression-free and overall survival.
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1 year
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Evaluate the prognostic significance of molecular detection of breast cancer cells in peripheral blood after initiation of systemic therapy.
Aikaikkuna: Until patient death
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Specifically, we will determine if molecular detection of circulating breast cancer cells after the initiation of systemic therapy is associated with a significantly decreased progression-free and overall survival.
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Until patient death
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Quantify baseline molecular marker expression levels in the peripheral blood of healthy volunteers
Aikaikkuna: Approximately 12 weeks
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Determine if baseline molecular marker expression levels are dependent on patient age, race, and/or the presence of benign breast disease.
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Approximately 12 weeks
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Compare molecular analyses to the results of the CellSeach assay
Aikaikkuna: Approximately 12 weeks
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Approximately 12 weeks
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Yhteistyökumppanit
Tutkijat
- Päätutkija: William E. Gillanders, M.D., Washington University School of Medicine
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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