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Profile of Soluble and Cellular Biomarkers and of Functional Imaging During Antiangiogenic Therapies in Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Cancer, Non-small Cell Lung Cancer, Renal Cell Cancer, Colorectal Cancer

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Trial Information

Profile of Soluble and Cellular Biomarkers and of Functional Imaging During Antiangiogenic Therapies in Cancer Patients


Inclusion Criteria:



- Age over 18 years

- Patients with HCC, NSCLC, RCC or CRC treated with an approved antiangiogenic drug
(bevacizumab, sorafenib, sunitinib)*

- Patients with at least one measurable lesion. Lesions must be measurable by CT-scan
or MRI (Magnetic resonance imaging) according to Response Evaluation Criteria in
Solid Tumours (RECIST)

Exclusion Criteria:

- Pregnant or breast-feeding patients. Women of childbearing potential must have a
negative pregnancy test performed within 7 days of the start of treatment. Both men
and women enrolled in this trial must use adequate birth control measures during the
course of the trial. The definition of effective contraception will be based on the
judgment of the principal investigator or a designated associate.

- Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

- Known or suspected allergy to the investigational agent or any agent given in
association with this trial -_> allergy

- MRI contraindications: implants (pacemaker)

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Progression free survival under antiangiogenic therapy

Outcome Description:

From date of study inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Outcome Time Frame:

progression of disease, up to 48 months

Safety Issue:

Yes

Principal Investigator

Wolfgang Hilbe, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University Innsbruck

Authority:

Austria: Agency for Health and Food Safety

Study ID:

Praemarker AAT 08

NCT ID:

NCT01507740

Start Date:

July 2009

Completion Date:

November 2014

Related Keywords:

  • Hepatocellular Cancer
  • Non-Small Cell Lung Cancer
  • Renal Cell Cancer
  • Colorectal Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms

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