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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
- E-post: karagkog@mskcc.org
Studer Kontakt Backup
- Navn: Julio Garcia-Aguilar, MD, PhD
- Telefonnummer: 212 639 5117
Studiesteder
-
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New Jersey
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Basking Ridge, New Jersey, Forente stater, 07920
- Rekruttering
- Memorial Sloan Kettering Basking Ridge
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Ta kontakt med:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
Middletown, New Jersey, Forente stater, 07748
- Rekruttering
- Memorial Sloan Kettering Monmouth
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Ta kontakt med:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
Montvale, New Jersey, Forente stater, 07645
- Rekruttering
- Memorial Sloan Kettering Bergen
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Ta kontakt med:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
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New York
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Commack, New York, Forente stater, 11725
- Rekruttering
- Memorial Sloan Kettering Suffolk - Commack
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Ta kontakt med:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
Harrison, New York, Forente stater, 10604
- Rekruttering
- Memorial Sloan Kettering Westchester
-
Ta kontakt med:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
-
Ta kontakt med:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
Ta kontakt med:
- Julio Garcia-Aguilar, MD,PhD
- Telefonnummer: 212-639-5117
-
Uniondale, New York, Forente stater, 11553
- Rekruttering
- Memorial Sloan Kettering Nassau
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Ta kontakt med:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Risk of residual disease and/or recurrent disease
Tidsramme: 5 years
|
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.
|
5 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Georgios Karagkounis, MD, Memorial Sloan Kettering Cancer Center
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
Andre studie-ID-numre
- 26-176
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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