- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00355316
A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients
19. Juni 2013 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
224
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Missouri
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St. Louis, Missouri, Vereinigte Staaten, 63110
- Washington University School of Medicine
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29425
- Medical University of South Carolina
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
16 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Sonstiges: Healthy Volunteers
Baseline blood draw.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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The prevalence of breast cancer cells in the peripheral blood
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Evaluate the prognostic significance of molecular detection of breast cancer cells in peripheral blood after initiation of systemic therapy.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Approximately 12 weeks
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Approximately 12 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: William E. Gillanders, M.D., Washington University School of Medicine
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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- Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
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- Mikhitarian K, Gillanders WE, Almeida JS, Hebert Martin R, Varela JC, Metcalf JS, Cole DJ, Mitas M. An innovative microarray strategy identities informative molecular markers for the detection of micrometastatic breast cancer. Clin Cancer Res. 2005 May 15;11(10):3697-704. doi: 10.1158/1078-0432.CCR-04-2164.
- Mitas M, Mikhitarian K, Hoover L, Lockett MA, Kelley L, Hill A, Gillanders WE, Cole DJ. Prostate-Specific Ets (PSE) factor: a novel marker for detection of metastatic breast cancer in axillary lymph nodes. Br J Cancer. 2002 Mar 18;86(6):899-904. doi: 10.1038/sj.bjc.6600190.
- Mitas M, Mikhitarian K, Walters C, Baron PL, Elliott BM, Brothers TE, Robison JG, Metcalf JS, Palesch YY, Zhang Z, Gillanders WE, Cole DJ. Quantitative real-time RT-PCR detection of breast cancer micrometastasis using a multigene marker panel. Int J Cancer. 2001 Jul 15;93(2):162-71. doi: 10.1002/ijc.1312.
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. November 2005
Primärer Abschluss (Tatsächlich)
1. November 2012
Studienabschluss (Tatsächlich)
1. Februar 2013
Studienanmeldedaten
Zuerst eingereicht
19. Juli 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Juli 2006
Zuerst gepostet (Schätzen)
21. Juli 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
21. Juni 2013
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. Juni 2013
Zuletzt verifiziert
1. Juni 2013
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 05-0435 / 201109033
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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