- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07769346
The Appendix Cancer PMP Research Foundation Natural History Study/Patient Registry
The ACPMP Research Foundation Appendix Cancer/PMP Patient Registry
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Margaret Najarian
- Numéro de téléphone: 704 (833) 227-6773
- E-mail: patientregistry@acpmp.org
Lieux d'étude
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Pennsylvania
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Springfield, Pennsylvania, États-Unis, 19064
- Recrutement
- ACPMP
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Contact:
- Margaret Najarian Patient Registry Coordinator
- Numéro de téléphone: 704 (833) 227-6773
- E-mail: patientregistry@acpmp.org
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Natural history and clinical course of appendix cancer and Pseudomyxoma Peritonei (PMP)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Disease Characteristics
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Deborah Shelton, ACPMP
- Chaise d'étude: Dr. Erin P. Ward, MD, University of Utah
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- Histoire naturelle
- Étude d'histoire naturelle
- Cancer rare
- Registre des patients
- Cancer appendiculaire
- Pseudomyxome péritonéal
- PMP
- LAMN
- Malignités de la surface péritonéale
- 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
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies intestinales
- Tumeurs par type histologique
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies gastro-intestinales
- Tumeurs intestinales
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Carcinome
- Maladies péritonéales
- Tumeurs, kystiques, mucineuses et séreuses
- Tumeurs abdominales
- Tumeurs cæcales
- Maladies cæcales
- Tumeurs péritonéales
- Adénocarcinome mucineux
- Tumeurs appendiculaires
- Pseudomyxome péritonéal
Autres numéros d'identification d'étude
- ACPMP-001
- NB500335 (Autre identifiant: North Star Review Board)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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