Skip to main content

Table 1 Brief description of the three clinical trials used to evaluate the feasibility of predictive modeling for eligibility screening

From: Evaluating predictive modeling algorithms to assess patient eligibility for clinical trials from routine data

Abbreviation Trial A
Full name European Surgical Outcome Study
Recruitment period 1 week, April 2011
Department Department of Anesthesiology
Inclusion criteria 1. older than 16 years
2. admitted for elective or non-elective inpatient surgery
Exclusion criteria 1. patients undergoing planned day-case surgery
2. patients undergoing cardiac surgery, neurosurgery, radiological or obstetric procedures
Abbreviation Trial B
Full name Sensitive polyprobe approach for improved prediction of therapy response and assessment of prognosis in colorectal cancer
Recruitment period 3 years, December 2009 – December 2012
Department Department of surgery
Inclusion criteria 1. initial diagnosis of histopathologically confirmed colorectal cancer of UICC stage I-IV
Exclusion criteria 1. inflammatory bowel disease (Crohn’s disease, Ulcerative colitis)
2. hereditary tumor syndromes like Familial Adenomatous polyposis (FAP), Hereditary nonpolyposis colorectal cancer (HNPCC)
Abbreviation Trial C
Full name Prospective Randomized Multicenter Phase-III-study: Preoperative Radiochemotherapy and Adjuvant Chemotherapy With 5-Fluorouracil Plus Oxaliplatin Versus Preoperative Radiochemotherapy and Adjuvant Chemotherapy With 5-Fluorouracil for Locally Advanced Rectal Cancer
Recruitment period 3.5 years, July 2006 – February 2010
Department Department of Radiation Oncology
Inclusion criteria 1. aged 18 years or older
2. histopathologically confirmed rectal carcinoma with an inferior margin no more than 12 cm above the anal verge, as assessed by rigid proctoscopy
3. evidence of perirectal fat infiltration (cT3–4) or lymph-node involvement (cN+), as assessed by endorectal ultra sound, multislice CT, or MRI
4. Eastern Cooperative Oncology Group (ECOG) performance status 2 or lower
5. adequate hematological, liver, and renal function
Exclusion criteria 1. metastatic disease
2. prior radiotherapy or chemotherapy
3. other cancers
4. pregnancy or lactation
5. clinically significant cardiac disease
6. known peripheral neuropathy
  1. UICC = Union for International Cancer Control, CT = X-ray computed tomography, MRI = Magnetic resonance imaging, CT3-4, cN+ = cancer stages according to TNM staging system.
Back to article page

BMC Medical Informatics and Decision Making

ISSN: 1472-6947

Contact us