Colorectal CancerPICC-1NCT01911988
Study of Association Between Peripheral Immune Cells and Recurrence in Stage II/III Colorectal Cancer
An observational study of Colorectal Cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to determine association between Peripheral Immune Cells(PIC) and recurrence in stage II/III colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2020
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage II /Stage III Colorectal Patients
Who may be able to join
- Clinically /Pahohistologically diagnosed as stageII/III CRC
- ECOG 0-2
- Age 18-90
- Gender both
Who cannot join
- Distant metastases noticed before or during surgery
- History of malignant tumor disease
- History of autoimmune diseases or immunodeficiencies
- History of hematological disease
- History of hepatic cirrhosis or Splenomegaly
- History of chronic kidney disease
Show all 13Show fewer
- History of organ transplant
- History of chronic inflammatory disease
- Use of hematological drugs within 1 year prior to surgery
- Use of immunodulatory drugs within 1 year prior to surgery
- Use of chemotherapeutic drugs within 1 year prior to surgery
- Long term Use of non-steroid anti-inflammatory drugs(>6 months)
- Unable or Unwilling to undergo all the standard treatment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine association between Peripheral Immune Cells(PIC) and recurrence in stage II/III colorectal cancer
Read the detailed description
The investigators hypothesize differentiation of Peripheral Immune Cells(PIC) would result in resistance of chemotherapy and tumor local of metastatic recurrence.
The primary endpoint of this study is Disease Free Survival and the secondary endpoint is 5-year Overall Survival.
5ml peripheral blood will be sorted and counted through flow cytometry at the point of before primary treatment(surgery for colon cancers, neoadjuvant therapy for rectal cancers) , before the first chemotherapy postoperatively and 1 month after last chemotherapy.
Patients will be followed up with 3 monthly assessments in the first two years and 6 monthly assessments in the rest three years. Stratification factors include age , BMI , gender , tumor location , rectal or colon cancer stage,the chemotherapy (FOLFOX, XELOX, DeGramont or Capecitabine ),laparoscopic or laprotomy, anastomosis, concomitant medications and complications.
- Conditions
- Colorectal Cancer
- Keywords
- Peripheral immune cells, Colorectal Cancers, Stage II/ Stage III, Recurrence, Metastasis
- Medical subject headings
- Colorectal Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colon&Rectal Stage II /Stage III | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
The time from resection to the time of disease recurrence(local or metastatic) or death from any cause.
Measured: 5 years
Secondary outcomes (1)
5 years overall survival
the time from resection to the time of death from any cause
Measured: 5 years or the time of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Cui, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Long Cui, MD, PhD, Study chair, Medical Center of Colon&Rectal Cancers, Shanghai Xinhua Hospital affiliated to Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911988
- Sponsor's protocol ID
- XHGC 001
- Acronym
- PICC-1
- Status last verified
- Oct 2016
- First submitted
- 23 Jul 2013
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Association Between Peripheral Immune Cells and Recurrence in Stage II/III Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01911988
- Acronym / sponsor ID
- PICC-1 / XHGC 001
- Conditions
- Colorectal Cancer
- Keywords
- Peripheral immune cells, Colorectal Cancers, Stage II/ Stage III, Recurrence, Metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2020 (estimated)
- First posted
- 30 Jul 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.
The purpose of this study is to determine association between Peripheral Immune Cells(PIC) and recurrence in stage II/III colorectal cancer
Detailed description
The investigators hypothesize differentiation of Peripheral Immune Cells(PIC) would result in resistance of chemotherapy and tumor local of metastatic recurrence.
The primary endpoint of this study is Disease Free Survival and the secondary endpoint is 5-year Overall Survival.
5ml peripheral blood will be sorted and counted through flow cytometry at the point of before primary treatment(surgery for colon cancers, neoadjuvant therapy for rectal cancers) , before the first chemotherapy postoperatively and 1 month after last chemotherapy.
Patients will be followed up with 3 monthly assessments in the first two years and 6 monthly assessments in the rest three years. Stratification factors include age , BMI , gender , tumor location , rectal or colon cancer stage,the chemotherapy (FOLFOX, XELOX, DeGramont or Capecitabine ),laparoscopic or laprotomy, anastomosis, concomitant medications and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colon&Rectal Stage II /Stage III | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage II /Stage III Colorectal Patients
Key inclusion criteria (4 listed)
- Clinically /Pahohistologically diagnosed as stageII/III CRC
- ECOG 0-2
- Age 18-90
- Gender both
Key exclusion criteria (13 listed)
- Distant metastases noticed before or during surgery
- History of malignant tumor disease
- History of autoimmune diseases or immunodeficiencies
- History of hematological disease
- History of hepatic cirrhosis or Splenomegaly
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
Disease Free Survival
Time frame: 5 years
The time from resection to the time of disease recurrence(local or metastatic) or death from any cause.
1 secondary outcome
5 years overall survival
Time frame: 5 years or the time of death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
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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.
Long Cui, MD, PhD study chair
Medical Center of Colon&Rectal Cancers, Shanghai Xinhua Hospital affiliated to Shanghai Jiaotong 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 Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 4 inclusion and 13 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 20 Oct 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?
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?
Disease Free Survival (time frame: 5 years). 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 20 Oct 2016.