- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07769346
The Appendix Cancer PMP Research Foundation Natural History Study/Patient Registry
The ACPMP Research Foundation Appendix Cancer/PMP Patient Registry
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
The ACPMP Research Foundation Appendix Cancer/PMP Patient Registry is a global, patient-powered natural history study designed to systematically collect longitudinal information from individuals affected by appendix cancer and Pseudomyxoma Peritonei (PMP).
The primary aim of the Registry is to improve understanding of these rare diseases, including their characteristics, clinical course, treatment patterns, and progression over time. Information collected through the Registry will help characterize the population affected by appendix cancer and PMP, support the development of recommendations and standards of care, and provide a resource for researchers studying disease biology, treatment outcomes, and accelerate the discovery of new treatments.
Participants, caregivers, and other authorized representatives provide information through a series of online surveys that include a prompt for patients to upload pathology reports, genomic sequencing, ctDNA reports and other relevant medical documents. Retrospective and prospective data collected include sociodemographic information, medical and diagnostic history, treatments, disease progression, management of care, and quality of life. Participants are asked to return periodically to update their information, allowing changes in disease and patient experience to be evaluated over time.
The Registry also serves as a resource to support future research and clinical trial development. With appropriate review and approval, Registry data may be used by researchers conducting retrospective studies or designing prospective studies of novel treatments. The Registry may also facilitate communication with participants about research opportunities and clinical trials for which they may be eligible.
The Registry is sponsored and managed by the Appendix Cancer Pseudomyxoma Peritonei (ACPMP) Research Foundation and is hosted on the National Organization for Rare Disorders (NORD) IAMRARE® platform. The study is conducted under Institutional Review Board (IRB) oversight and follows established procedures for the collection, management, protection, and appropriate research use of participant data.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Margaret Najarian
- Telefonnummer: 704 (833) 227-6773
- E-Mail: patientregistry@acpmp.org
Studienorte
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Pennsylvania
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Springfield, Pennsylvania, Vereinigte Staaten, 19064
- Rekrutierung
- ACPMP
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Kontakt:
- Margaret Najarian Patient Registry Coordinator
- Telefonnummer: 704 (833) 227-6773
- E-Mail: patientregistry@acpmp.org
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Diagnosis of appendix cancer.
- Meets the study inclusion criteria for participation.
- Participant or, when applicable, a legally authorized representative (LAR) is able to provide informed consent and enter information into the Registry.
- A designated representative may provide retrospective information for an individual who died from appendix cancer, as permitted by the study protocol.
Exclusion Criteria:
- Individuals who do not meet the study inclusion criteria.
- Individuals for whom required informed consent cannot be obtained.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Participants with Appendix Cancer and/or Pseudomyxoma Peritonei (PMP)
Individuals diagnosed with appendix cancer and/or Pseudomyxoma Peritonei (PMP) who enroll in the ACPMP Research Foundation Appendix Cancer/PMP Patient Registry.
Participants, caregivers, or authorized representatives provide health and disease-related information through online surveys and may periodically update their information over time.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Natural history and clinical course of appendix cancer and Pseudomyxoma Peritonei (PMP)
Zeitfenster: Up to 5 years
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Characterization of the natural history and clinical course of appendix cancer and Pseudomyxoma Peritonei (PMP) using participant- and caregiver-reported data collected through the ACPMP Patient Registry.
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Up to 5 years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Disease Characteristics
Zeitfenster: Up to 5 years
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Disease characteristics of appendix cancer and pseudomyxoma peritonei (PMP), including disease type, extent, and other participant-reported disease characteristics.
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Up to 5 years
|
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Treatment History
Zeitfenster: Up to 5 years
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Cancer treatment history, including surgical procedures, chemotherapy, and other treatments received for appendix cancer and PMP.
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Up to 5 years
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Diagnosis
Zeitfenster: Up to 5 years
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Characteristics and timing of diagnosis of appendix cancer and PMP, including initial diagnosis and diagnostic findings.
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Up to 5 years
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Disease Progression
Zeitfenster: Up to 5 years
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Disease progression over time, based on participant- and caregiver-reported information regarding changes in disease status.
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Up to 5 years
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Management of Care
Zeitfenster: Up to 5 years
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Changes in management of care for appendix cancer and PMP, including treatments, procedures, and changes in care over time.
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Up to 5 years
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Signs and Symptoms
Zeitfenster: Up to 5 years
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Changes in signs and symptoms associated with appendix cancer and PMP over time, based on participant- and caregiver-reported data.
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Up to 5 years
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Deborah Shelton, ACPMP
- Studienstuhl: Dr. Erin P. Ward, MD, University of Utah
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Naturgeschichte
- Naturhistorische Studie
- Seltener Krebs
- Patientenregister
- Blinddarmkrebs
- Pseudomyxoma peritonei
- PMP
- LAMN
- Peritoneale Oberflächenmalignome
- Appendiceal Adenocarcinoma
- Appendix Cancer
- Appendiceal Neoplasm
- Appendiceal Neoplasms
- Peritoneal Surface Malignancy
- Goblet Cell
- Signet Ring Cell
- Low-Grade Appendiceal Mucinous Neoplasm
- High-Grade Appendiceal Mucinous Neoplasm
- HAMN
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach Standort
- Neubildungen
- Darmerkrankungen
- Neubildungen nach histologischem Typ
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmtumoren
- Neubildungen, Drüsen und Epithelien
- Adenokarzinom
- Karzinom
- Peritonealerkrankungen
- Neubildungen, zystische, schleimige und seröse
- Abdominelle Neubildungen
- Cecal Neoplasmen
- Blinddarmerkrankungen
- Peritoneale Neubildungen
- Adenokarzinom, muzinös
- Appendix-Neubildungen
- Pseudomyxoma peritonei
Andere Studien-ID-Nummern
- ACPMP-001
- NB500335 (Andere Kennung: North Star Review Board)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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