Malignant Polyp Registry
The purpose of this study is to learn more about malignant colorectal polyps and the risk of the cancer remaining, coming back, or spreading after the polyp is removed. The researchers also want to understand how patients and doctors make decisions about treatment after a malignant polyp is removed.
Additionally, the researcher will collect information medical records, including results from tests, imaging scans, lab work, and pathology reports. The researchers may also collect images from your colonoscopy and copies of pathology slides the polyp. The researchers will also follow the patient's health over time through regular doctor visits. If the patient does not have a scheduled visit, a member of the study team will contact the patient by phone at 1 year, 3 years, and 5 years after the patient joins the study to ask about their health.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Georgios Karagkounis, MD
- Telefoonnummer: 212-639-2269
- E-mail: karagkog@mskcc.org
Studie Contact Back-up
- Naam: Julio Garcia-Aguilar, MD, PhD
- Telefoonnummer: 212 639 5117
Studie Locaties
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New Jersey
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Basking Ridge, New Jersey, Verenigde Staten, 07920
- Werving
- Memorial Sloan Kettering Basking Ridge
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Contact:
- Georgios Karagkounis, MD
- Telefoonnummer: 212-639-2269
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Middletown, New Jersey, Verenigde Staten, 07748
- Werving
- Memorial Sloan Kettering Monmouth
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Contact:
- Georgios Karagkounis, MD
- Telefoonnummer: 212-639-2269
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Montvale, New Jersey, Verenigde Staten, 07645
- Werving
- Memorial Sloan Kettering Bergen
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Contact:
- Georgios Karagkounis, MD
- Telefoonnummer: 212-639-2269
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New York
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Commack, New York, Verenigde Staten, 11725
- Werving
- Memorial Sloan Kettering Suffolk - Commack
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Contact:
- Georgios Karagkounis, MD
- Telefoonnummer: 212-639-2269
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Harrison, New York, Verenigde Staten, 10604
- Werving
- Memorial Sloan Kettering Westchester
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Contact:
- Georgios Karagkounis, MD
- Telefoonnummer: 212-639-2269
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New York, New York, Verenigde Staten, 10065
- Werving
- Memorial Sloan Kettering Cancer Center
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Contact:
- Georgios Karagkounis, MD
- Telefoonnummer: 212-639-2269
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Contact:
- Julio Garcia-Aguilar, MD,PhD
- Telefoonnummer: 212-639-5117
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Uniondale, New York, Verenigde Staten, 11553
- Werving
- Memorial Sloan Kettering Nassau
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Contact:
- Georgios Karagkounis, MD
- Telefoonnummer: 212-639-2269
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Criteria:
- Documentation of Disease
- Patients must have one malignant polyp, pathologically confirmed within 90 days of enrollment. Patients with multiple malignant polyps are not eligible.
- Definition of Disease Colorectal carcinoma (CRC) develops within serrated or adenomatous polyps. Early CRC represents invasion into the submucosa and frequently presents within the precursor polyp which is termed a 'malignant polyp'(23).
The term malignant polyp specifically refers to a colorectal lesion with cancer invading the submucosa but not extending into the muscularis propria. These lesions are classified as pT1 in the TNM classification system (24)
Prior Treatment Endoscopic resection of the polypoid lesion-malignant polyp with simple snare polypectomy, conventional endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD) (25).
- Age ≥ 18
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Risk of residual disease and/or recurrent disease
Tijdsspanne: 5 years
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Residual disease analysis will be limited to patients who underwent surgery (in addition to endoscopic resection).
Participants will be evaluable if they undergo adequate pathological assessment of the resected specimen.Adequate assessment is defined as histopathological evaluation of all relevant tissue specimens with a documented report.
Participants with incomplete or inadequate pathological assessments will be considered inevaluable.
Risk of residual disease will be estimated using the Kaplan-Meier method and reported with 95% confidence intervals.
Local recurrence is defined by the reappearance of disease at or near the primary site.
The date of diagnosis and anatomical site of recurrence will be documented.
Distant recurrence is defined by disease spread to sites distant from the primary lesion.
The date of diagnosis and specific sites involved will be documented.
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5 years
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Georgios Karagkounis, MD, Memorial Sloan Kettering Cancer Center
Publicaties en nuttige links
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
Andere studie-ID-nummers
- 26-176
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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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