CLB-9581 Klinik Çalışmasında Tedavi Edilen Evre II Kolon Kanseri Hastalarından Alınan Doku Örneklerinin İncelenmesi

Sade dilde özet

Bu çalışma, daha önce CLB-9581 (CALGB 9581) klinik çalışmasında tedavi görmüş Evre II kolon kanseri (colon cancer) hastalarından alınan doku örneklerini, laboratuvar biyobelirteç analizleriyle incelemiştir. Çalışmaya, CALGB 9581 veya 89803 çalışmalarına kayıtlı ve yeterli örneği bulunan hastalar dahil edilmiştir. Alliance for Clinical Trials in Oncology tarafından yürütülen çalışma faz uygulanmayan türde olup tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Tamamlandı

Sponsor

Alliance for Clinical Trials in Oncology

Müdahale

laboratory biomarker analysis

Başlangıç

01.07.2007

Tahmini bitiş

01.02.2019

Ülkeler

United States

İlgili genler

Merkezler

• Boston, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Registration to CALGB 9581 or 89803
* Samples present within the CALGB Pathology Coordinating Office (PCO) or at the institutions providing treatment that are sufficient to meet study aims
* Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
* CALGB does not require that a separate consent form be signed for this study:

  * The subject population to be studied in this protocol includes patients selected from either of the following CALGB treatment protocols: CALGB 9581 or 89803; all such patients have signed (or will sign) a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into those trials
  * All samples to be studied are obtained and stored as part of the patient's respective treatment trial; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
  * There should be no physical, psychological, social, or legal risks associated with this study; no invasive procedures are recommended or requested
  * All appropriate and necessary procedures will be utilized to maintain confidentiality; all patients who have had samples submitted for analysis will have their CALGB study number used to identify specimens
  * This study does not require direct patient contact and no specific risk or benefits to individuals involved in the trial are anticipated; it is likely, however, that the information gained will substantially help similar patients in the future