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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
- E-post: karagkog@mskcc.org
Studera Kontakt Backup
- Namn: Julio Garcia-Aguilar, MD, PhD
- Telefonnummer: 212 639 5117
Studieorter
-
-
New Jersey
-
Basking Ridge, New Jersey, Förenta staterna, 07920
- Rekrytering
- Memorial Sloan Kettering Basking Ridge
-
Kontakt:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
Middletown, New Jersey, Förenta staterna, 07748
- Rekrytering
- Memorial Sloan Kettering Monmouth
-
Kontakt:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
Montvale, New Jersey, Förenta staterna, 07645
- Rekrytering
- Memorial Sloan Kettering Bergen
-
Kontakt:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
-
New York
-
Commack, New York, Förenta staterna, 11725
- Rekrytering
- Memorial Sloan Kettering Suffolk - Commack
-
Kontakt:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
Harrison, New York, Förenta staterna, 10604
- Rekrytering
- Memorial Sloan Kettering Westchester
-
Kontakt:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
New York, New York, Förenta staterna, 10065
- Rekrytering
- Memorial Sloan Kettering Cancer Center
-
Kontakt:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
Kontakt:
- Julio Garcia-Aguilar, MD,PhD
- Telefonnummer: 212-639-5117
-
Uniondale, New York, Förenta staterna, 11553
- Rekrytering
- Memorial Sloan Kettering Nassau
-
Kontakt:
- Georgios Karagkounis, MD
- Telefonnummer: 212-639-2269
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Risk of residual disease and/or recurrent disease
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Georgios Karagkounis, MD, Memorial Sloan Kettering Cancer Center
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 26-176
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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