- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07769346
The Appendix Cancer PMP Research Foundation Natural History Study/Patient Registry
The ACPMP Research Foundation Appendix Cancer/PMP Patient Registry
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Margaret Najarian
- Telefonnummer: 704 (833) 227-6773
- E-post: patientregistry@acpmp.org
Studiesteder
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Pennsylvania
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Springfield, Pennsylvania, Forente stater, 19064
- Rekruttering
- ACPMP
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Ta kontakt med:
- Margaret Najarian Patient Registry Coordinator
- Telefonnummer: 704 (833) 227-6773
- E-post: patientregistry@acpmp.org
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Natural history and clinical course of appendix cancer and Pseudomyxoma Peritonei (PMP)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Disease Characteristics
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Deborah Shelton, ACPMP
- Studiestol: Dr. Erin P. Ward, MD, University of Utah
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- Naturlig historie
- Naturhistorisk studie
- Sjelden kreft
- Pasientregister
- Blindtarmskreft
- Pseudomyxoma Peritonei
- PMP
- LAMN
- Peritoneale overflatemaligniteter
- 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
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Tarmsykdommer
- Neoplasmer etter histologisk type
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Intestinale neoplasmer
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Karsinom
- Peritoneale sykdommer
- Neoplasmer, cystiske, mucinøse og serøse
- Abdominale neoplasmer
- Cecal neoplasmer
- Cecal sykdommer
- Peritoneale neoplasmer
- Adenokarsinom, slimete
- Appendiceale neoplasmer
- Pseudomyxoma Peritonei
Andre studie-ID-numre
- ACPMP-001
- NB500335 (Annen identifikator: North Star Review Board)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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