Rectal NeoplasmsNCT02554448
Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy
A study testing ISET system in people with Rectal Neoplasms and Circulating Tumor Cells, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the value of dynamic change in detecting CTCs in peripheral blood from stage III rectal cancer patients undergoing neoadjuvant Folfox treatment and chemoradiotherapy,before and after surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rectal Neoplasms, Circulating Tumor Cells
- What is being tested?
- ISET system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: >18 years old.
- Diagnosis of stage III rectal cancer based on histology.
- Will receive neoadjuvant treatment using Folfox or chemoradiotherapy .
- Life expectancy: Greater than 3 months.
- Patients have no severe inflammation, such as vasculitis.
- Ability to understand the study protocol and a willingness to sign a written informed consent document
Who cannot join
- Patients with other primary tumor except rectal cancer.
- History of coagulation disorders or anemia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Yanxin Luo, PhD, +86-13826190263, luoyx25@mail.sysu.edu.cn
Weida Lin, master, +86-13430354015, linweida529@163.com
About this study
The purpose of this study is to evaluate the value of dynamic change in detecting CTCs in peripheral blood from stage III rectal cancer patients undergoing neoadjuvant Folfox treatment and chemoradiotherapy,before and after surgery.
Read the detailed description
Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration of CTCs in rectal cancer patients could play an important role in diagnosis, predicting the risk for tumor recurrence and effectiveness of neoadjuvant therapy.
The investigators choose several timepoints to detect the dynamic change of CTCs,1 day before the 1st ,3rd and 5th(if the patient needs before surgery) neoadjuvant therapy course,1 day before and 7days ,3 month,6 month after surgery. Approximately 7.5-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with rectal cancer . Briefly, the number of CTCs will be count by the cellsearch system , recorded and analysed by the investigator.
- Conditions
- Rectal Neoplasms, Circulating Tumor Cells
- Being tested
- ISET system
- Keywords
- Circulating Tumor Cells, rectal Neoplasms, neoadjuvant otherapy
- Medical subject headings
- Rectal Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISET systemOther
Use ISET system to test the number of CTCs from patients before and during treatment.
| Study group | Role | What they receive |
|---|---|---|
| Circulating Tumor Cells | Experimental | Use ISET system to test the number of CTCs from patients before and during treatment. Receives: Other: ISET system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of Circulating Tumor Cells (CTCs)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanxin Luo, PhD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554448
- Sponsor's protocol ID
- CTC-1
- Status last verified
- Apr 2016
- First submitted
- 17 Sep 2015
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: not ready to share the data
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT02554448
- Acronym / sponsor ID
- CTC-1
- Conditions
- Rectal Neoplasms, Circulating Tumor Cells
- Keywords
- Circulating Tumor Cells, rectal Neoplasms, neoadjuvant otherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Sep 2015 (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.
The purpose of this study is to evaluate the value of dynamic change in detecting CTCs in peripheral blood from stage III rectal cancer patients undergoing neoadjuvant Folfox treatment and chemoradiotherapy,before and after surgery.
Detailed description
Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration of CTCs in rectal cancer patients could play an important role in diagnosis, predicting the risk for tumor recurrence and effectiveness of neoadjuvant therapy.
The investigators choose several timepoints to detect the dynamic change of CTCs,1 day before the 1st ,3rd and 5th(if the patient needs before surgery) neoadjuvant therapy course,1 day before and 7days ,3 month,6 month after surgery. Approximately 7.5-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with rectal cancer . Briefly, the number of CTCs will be count by the cellsearch system , recorded and analysed by the investigator.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Circulating Tumor Cells | Experimental | Other: ISET systemUse ISET system to test the number of CTCs from patients before and during treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: >18 years old.
- Diagnosis of stage III rectal cancer based on histology.
- Will receive neoadjuvant treatment using Folfox or chemoradiotherapy .
- Life expectancy: Greater than 3 months.
- Patients have no severe inflammation, such as vasculitis.
Key exclusion criteria (2 listed)
- Patients with other primary tumor except rectal cancer.
- History of coagulation disorders or anemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISET systemUse ISET system to test the number of CTCs from patients before and during treatment. | Other | Circulating Tumor Cells |
Primary outcome
The number of Circulating Tumor Cells (CTCs)
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Individual participant dataSharing planned: No. not ready to share the data
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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.
Yanxin Luo, PhD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISET system in people with Rectal Neoplasms and Circulating Tumor Cells, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 6 inclusion and 2 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 1 Jun 2016. 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 China. 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?
Contact Yanxin Luo, PhD (+86-13826190263, luoyx25@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of Circulating Tumor Cells (CTCs) (time frame: 6 month). 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 1 Jun 2016.