Colorectal CancerNCT00918827
Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy
An observational study of Colorectal Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who have undergone surgery and chemotherapy may help doctors predict how well patients will respond to treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- How many people
- 2,128 participants
- Where
- 1 siteJapan
- Study dates
- 1 Apr 2009to 31 Mar 2017
- 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: Pathologically confirmed stage III colon adenocarcinoma patients who are given treatment with fluorouracil-based post-opeartive adjuvant chemotherapy
<Inclusion criteria>
- Pathologically confirmed stage III colon adenocarcinoma
- Curatively resected (R0)
- Patients scheduled for treatment with fluorouracil-based post-operative adjuvant chemotherapy
- Provided written informed consent
<Exclusion criteria>
- Synchronous or metachronous multiple cancers
- Contraindications for fluorouracil-based chemotherapy
- Patients who have initiated neo-adjuvant chemotherapy or radiotherapy prior to participating in this study
- Ineligible patients according to the investigator's judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who have undergone surgery and chemotherapy may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is looking at tumor samples from patients with stage III colon cancer who have undergone surgery and chemotherapy.
Read the detailed description
OBJECTIVES:
- Identify predictive factors of efficacy and safety of adjuvant chemotherapy comprising fluorouracil-based regimens in patients with stage III colon cancer.
- Investigate possibility of "personalized treatment" with adjuvant chemotherapy based on the predictive factors identified.
OUTLINE: Patients' tumor tissue samples are collected for protein expression levels of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), VEGF, EGFR, mRNA-expression levels of TP, DPD, thymidylate synthase (TS), and orotate phosphoribosyl transferase (OPRT) by ELISA, Human Duo Set, and RT-PCR assays.
Patients' enzyme expression levels are compared with their clinical data.
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the colon, stage III colon cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival
Measured: 5 years after the end of registration
Relationship between expression levels of enzymes and adverse effects
Measured: 5 years after the end of registration
Disease-free survival
Measured: Until the day on which an event reveals during the 5 year observational period
Relapse-free survival
Measured: Until the day on which an event reveals during the 5 year observational period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study start1 Apr 2009
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Tokyo Medical and Dental University
- Responsible party
- Sponsor
- Investigators
- Kenichi Sugihara, MD, PhD, Principal investigator, Tokyo Medical and Dental University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918827
- Sponsor's protocol ID
- CDR0000642386
- Other IDs
- TMDU-TRICC0807, UMIN000002013
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2009
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ishiguro M, Kotake K, Nishimura G, Tomita N, Ichikawa W, Takahashi K, Watanabe T, Furuhata T, Kondo K, Mori M, Kakeji Y, Kanazawa A, Kobayashi M, Okajima M, Hyodo I, Miyakoda K, Sugihara K. Study protocol of the B-CAST study: a multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer. BMC Cancer. 2013 Mar 25;13:149. doi: 10.1186/1471-2407-13-149.
PubMed 23530572
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)
- ClinicalTrials.gov ID
- NCT00918827
- Acronym / sponsor ID
- CDR0000642386
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the colon, stage III colon cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,128 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Tokyo Medical and Dental University
- Study start
- 1 Apr 2009
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 11 Jun 2009 (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.
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who have undergone surgery and chemotherapy may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is looking at tumor samples from patients with stage III colon cancer who have undergone surgery and chemotherapy.
Detailed description
OBJECTIVES:
- Identify predictive factors of efficacy and safety of adjuvant chemotherapy comprising fluorouracil-based regimens in patients with stage III colon cancer.
- Investigate possibility of "personalized treatment" with adjuvant chemotherapy based on the predictive factors identified.
OUTLINE: Patients' tumor tissue samples are collected for protein expression levels of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), VEGF, EGFR, mRNA-expression levels of TP, DPD, thymidylate synthase (TS), and orotate phosphoribosyl transferase (OPRT) by ELISA, Human Duo Set, and RT-PCR assays.
Patients' enzyme expression levels are compared with their clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pathologically confirmed stage III colon adenocarcinoma patients who are given treatment with fluorouracil-based post-opeartive adjuvant chemotherapy
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
Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival
Time frame: 5 years after the end of registration
Relationship between expression levels of enzymes and adverse effects
Time frame: 5 years after the end of registration
Disease-free survival
Time frame: Until the day on which an event reveals during the 5 year observational period
Relapse-free survival
Time frame: Until the day on which an event reveals during the 5 year observational period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Derived from this study: PubMed 23530572Ishiguro M, Kotake K, Nishimura G, Tomita N, Ichikawa W, Takahashi K, Watanabe T, Furuhata T, Kondo K, Mori M, Kakeji Y, Kanazawa A, Kobayashi M, Okajima M, Hyodo I, Miyakoda K, Sugihara K. Study protocol of the B-CAST study: a multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer. BMC Cancer. 2013 Mar 25;13:149. doi: 10.1186/1471-2407-13-149.
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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.
Kenichi Sugihara, MD, PhD principal investigator
Tokyo Medical and Dental University
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 Colorectal Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival (time frame: 5 years after the end of registration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00918827, which also lists 1 linked publication.
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 2 Jun 2017.