Patients Who Refractory Cancer Conqueror for Bio New Drug Development Translational Research Establishment

NCT01932047 | Unknown

• 1 other identifier: 2010-04-004
• Study Type: observational
• Target: 1,523
• Locations: 1 country
• Sites: 1

Brief Summary

■ Unmet medical needs for Refractory cancer Conquest \- Many advanced cancers are still detected Despite remarkable technological advances for the early diagnosis of cancer in the field last 20 years. In the type of progressive carcinoma is very high malignancy despite a variety of therapeutic target treatment for refractory cancer. The refractory cancer patients who main focus of this research defined as the adult solid tumor patients who have failed standard therapy according to the criteria NCCN / ASCO (American Society of imsangam) / KCSG (Study Group for chemotherapy). The survival rate of refractory cancer patients are estimated to be 30-40% of the total patients with metastatic solid tumors and these refractory cancers are difficult to deal with or control to conventional treatment so shows almost close to 100% mortality. Therefore the new development of therapies for conquer of refractory cancer are urgently required. ■ Preclinical translational research Unmet Needs of Bio-new drug development for conquer of refractory cancer \- The stage of preclinical translational research (Translational Research) connects between the early stages of development and clinical trials in the stage drug development. The establishment of foundation based on the translational research is very necessary and this must have proven ability to treat refractory cancer. The most anti-cancer drugs developed by existing preclinical testing method actually does not show a remarkable effect in many cases in the clinical trials, even if showed a remarkable inhibitory cancer effect in animal testing. The exact molecular diagnosis to treat targets and paradigm for the development of new drugs at the same time requires for target treatment. The tailored cell lines by patients and the proven technology by animal models and unmet need for preclinical translational research is increasing

Conditions

Refractory Cancer

Outcome Measures

Primary Outcomes (1)

• The amount of sample size

  ■ Target number of subjects (years) GBM : 120 case Colon Cancer : 200 case Gastric Cancer : 345 case Ovarian Cancer : 40 case Lung Cancer : 30 case Breast Cancer : 100 case Brain metastases : 120 case Bone metastases : 50 case Lymphoma : 10 case Pancreatic Cancer : 100 case Gall Bladder cancer : 20 case Prostate Cancer : 50 case Kidney Cancer : 100 case Bladder Cancer : 200 case Osteosarcoma : 15 case Soft tissue sarcoma : 50 case Head \& neck cancer : 30 case Other Brain tumor : 100case \- Total case : 1680 case

  10years

Secondary Outcomes (1)

• The size of real tumor portion on obtained tumor specimen

  10 years

Other Outcomes (1)

• Genomic DNA Extraction from blood specimen

  10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subject diagnosed with cancer(GBM, Colon Cancer, Ovarian Cancer, Lung Cancer, Breast Cancer, Brain metastases, Bone Metastatic Cancer, Lymphoma, Gastric Cancer, Pancreatic Cancer, Gall bladder Cancer, Prostate Cancer, Kidney Cancer, Bladder cancer, Osteosarcoma, Soft tissue sarcoma, Head and neck cancer),and other Brain tumor

You may qualify if:

• The patients who agreed and written consent to participate in this research
• The patients who are scheduled for collection such as the patient tissue, pleural fluid, cerebro spinal fluid, blood samples for the purpose of surgery and diagnostics
• The patients who diagnosed with cancer as below - GBM, Colon Cancer, Ovarian Cancer, Lung Cancer, Breast Cancer, Brain metastases, Lymphoma, Bone Metastatic Cancer , Gastric Cancer, Pancreatic Cancer, Gall bladder Cancer, Prostate Cancer, Kidney Cancer, Bladder cancer, Osteosarcoma, Soft tissue sarcoma, Head and neck cancer, 기타 Brain tumor

You may not qualify if:

• \) Those who do not agree in writing to participate in research

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gyunggido, 135-710, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

* The problem with the existing pre-clinical testing technology 1. Efficacy evaluation using existing cell lines 2. Existing preclinical animal models (The tumors produced by the cancer cells subcutaneously injected into immunodeficient mice) * The solution plan 1. The development of patient-specific personalized cell library 2. The development of stereotactic(orthotopic) personalized animal models with the patient-derived cell lines derived from patients

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jueun Kim, Coordinator

  Institutional Refractory Cancer Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 30, 2013
• Study Start: April 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: April 1, 2015
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

KR (1)