Refractory CancerNCT01932047
Patients Who Refractory Cancer Conqueror for Bio New Drug Development Translational Research Establishment
An observational study of Refractory Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refractory Cancer
- How many people
- 1,523 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Apr 2015
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 1) Those who do not agree in writing to participate in research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients Who Refractory Cancer Conqueror for Bio New Drug Development Translational Research Establishment - Establishment of Personalized Cell Library
■ 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.
Read more
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
Read the detailed description
■ The specimen obtainer in surgery room contact with the manager of Institute Refractory Cancer Research team by calling to Medi-call system(Phone No.system T.9825).
The specimen obtainer gives the information of speciman to the manager .
The manager contact to the speciman deleverer and The speciman deleverer transported the specimens safely to the laboratory space.
The written informed consent form should obtained from the subject prior to the surgery.
In the case of blood samples, The total 15 ~ 20 ㎖ blood (only once) extracted from the subject and about 10 ~ 15 ㎖ blood is used for the genomic DNA extraction.
- Conditions
- Refractory Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10years
Secondary outcomes (1)
The size of real tumor portion on obtained tumor specimen
- In the samples of frozen tissue stored at -80 ° C are processed by the method Frozen Hematoxylin \& Eosin Stain.
- The criteria of evaluation : tumor size, Tumor Area, Tumor Cell Density, Tumor Nucleus Amount, Necrosis.
- The Results are distincted by Accept, Intermediate, Fail.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startApr 2010
- Primary completionAug 2013
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,523 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-hyun Nam, Samsung Medical Center
- Investigators
- Jueun Kim, Coordinator, Study director, Institutional Refractory Cancer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932047
- Sponsor's protocol ID
- 2010-04-004
- Status last verified
- Aug 2013
- First submitted
- 27 Aug 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Who Refractory Cancer Conqueror for Bio New Drug Development Translational Research Establishment - Establishment of Personalized Cell Library
- ClinicalTrials.gov ID
- NCT01932047
- Acronym / sponsor ID
- 2010-04-004
- Conditions
- Refractory Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,523 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Apr 2015 (estimated)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
■ 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
Detailed description
■ The specimen obtainer in surgery room contact with the manager of Institute Refractory Cancer Research team by calling to Medi-call system(Phone No.system T.9825).
The specimen obtainer gives the information of speciman to the manager .
The manager contact to the speciman deleverer and The speciman deleverer transported the specimens safely to the laboratory space.
The written informed consent form should obtained from the subject prior to the surgery.
In the case of blood samples, The total 15 ~ 20 ㎖ blood (only once) extracted from the subject and about 10 ~ 15 ㎖ blood is used for the genomic DNA extraction.
Study design
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1) Those who do not agree in writing to participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The amount of sample size
Time frame: 10years
■ 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
1 secondary outcome
The size of real tumor portion on obtained tumor specimen
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jueun Kim, Coordinator study director
Institutional Refractory Cancer Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of sample size (time frame: 10years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.