- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02587026
Biorepository for Precision Genomics
Collection of Specimens and Clinical Data to Create a Biorepository for Precision Genomics
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46202
- Indiana University Melvin and Bren Simon Cancer Center
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Muncie, Indiana, Vereinigte Staaten, 47303
- IU Health Ball Memorial
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Patients must have histologically or cytologically confirmed malignancy or related disorder. This includes patients with active disease as well as those in remission.
One of the following tissue collection situations
- Group 1: Patients having tissue collection for clinical reasons who are willing to have additional specimens taken for research (biopsy may be done under local anesthesia, intravenous conscious sedation, or general anesthesia, as clinically indicated)
- Group 2: Patients willing to undergo tissue collection for the purpose of research only (biopsy may be done under local anesthesia or intravenous conscious sedation per the judgment of the treating physician). This may include collection of additional samples from patients undergoing a study-specific research biopsy/procedure. Patients in group 2 may not undergo general anesthesia as part of this protocol.
- Group 3: Patients having tissue collection for clinical reasons who are willing to have excess tissue (i.e., tissue that would have otherwise been discarded) banked for research (biopsy may be done under local anesthesia, intravenous conscious sedation, or general anesthesia, as clinically indicated).
- Willingness to undergo phlebotomy for research blood samples Additional Criteria for Patients in Groups 1 and 2
- PT and PTT levels < 1.2 x the institutional ULN (PT, PTT not required for skin biopsies)
- Not receiving therapeutic anticoagulation
- Platelets ≥ 100 x 109/L
Exclusion Criteria:
- Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine)
Any other condition, which in the opinion of the patient's treating oncologist or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.
Additional Criteria for Patients in Group 1 and 2
- Pregnant women are excluded from Groups 1 and 2 because there may be an increased risk to both mother and fetus in the setting of conscious sedation, which is required for biopsies of certain anatomic sites (e.g. liver, lung, bone). Also, ionizing radiation from CT-guided biopsies may pose a risk to the unborn fetus.
Patients in Groups 1 and 2 may not have active cardiac disease, defined as:
- History of uncontrolled or symptomatic angina
- History of arrhythmias requiring medications, or clinically significant
- Myocardial infarction < 6 months from study entry
- Uncontrolled or symptomatic congestive heart failure
- Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
- Patients in group 1 and 2 receiving bevacizumab or other angiogenesis inhibitors (or less than 6 weeks from last dose of an angiogenesis inhibitor) should not undergo a research core liver biopsy on this protocol because of the concern for the possibility of increased bleeding risk. Patients may undergo a research fine needle aspiration (FNA) of the liver as an alternative. Patients may also undergo core research biopsies of other sites, up to the discretion of the treating physician, but physicians should take the potential increased bleeding and/or delayed wound healing issues into consideration.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Sonstiges
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Biorepository for precision genomics
Zeitfenster: From time of patient consent (day 1) to time of sample collection (which can occur on day 1-day 35)
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Blood and tissue sample collection for use in future basic and translational research studies
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From time of patient consent (day 1) to time of sample collection (which can occur on day 1-day 35)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Bryan P Schneider, MD, Vera Bradley Professor of Oncology, Professor of Medicine, Professor of Medical & Molecular Genetics
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- IUSCC-0534
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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