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- Klinische proef NCT07769346
The Appendix Cancer PMP Research Foundation Natural History Study/Patient Registry
The ACPMP Research Foundation Appendix Cancer/PMP Patient Registry
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Margaret Najarian
- Telefoonnummer: 704 (833) 227-6773
- E-mail: patientregistry@acpmp.org
Studie Locaties
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Pennsylvania
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Springfield, Pennsylvania, Verenigde Staten, 19064
- Werving
- ACPMP
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Contact:
- Margaret Najarian Patient Registry Coordinator
- Telefoonnummer: 704 (833) 227-6773
- E-mail: patientregistry@acpmp.org
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Natural history and clinical course of appendix cancer and Pseudomyxoma Peritonei (PMP)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Disease Characteristics
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Deborah Shelton, ACPMP
- Studie stoel: Dr. Erin P. Ward, MD, University of Utah
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- Natuurlijke geschiedenis
- Natuurhistorisch onderzoek
- Zeldzame kanker
- Patiëntenregistratie
- Blindedarmkanker
- Pseudomyxoma Peritonei
- PMP
- LAMN
- Maligniteiten van het peritoneale oppervlak
- 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
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Darmziekten
- Neoplasmata per histologisch type
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Intestinale neoplasmata
- Neoplasmata, glandulair en epitheel
- Adenocarcinoom
- Carcinoom
- Peritoneale ziekten
- Neoplasmata, cysteus, slijmerig en sereus
- Abdominale neoplasmata
- Cecal neoplasmata
- Cecale ziekten
- Peritoneale neoplasmata
- Adenocarcinoom, slijmerig
- Appendicale neoplasmata
- Pseudomyxoma Peritonei
Andere studie-ID-nummers
- ACPMP-001
- NB500335 (Andere identificatie: North Star Review Board)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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