Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer
1 other identifier
observational
100
1 country
1
Brief Summary
Rectal cancer is one of the most common malignant tumors in the world. However, there's also no reliable and sensitive method to monitor diseases and evaluate therapy responses till now. Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a promising method in this field. This study is to investigate the role of circulating tumor cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
August 24, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedAugust 24, 2012
August 1, 2012
July 19, 2012
August 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
circulating tumor cells level changes after radiotherapy
3 years
Secondary Outcomes (5)
overall survival
3 years
disease-free survival
3 years
serum carcinoembryonic antigen (CEA) level
3 years
pathological response (tumor regression grade)if surgery
3 years
RECIST-based tumor response at 10 week after radiotherapy
3 years
Study Arms (1)
rectal cancer with stage II-IV
rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin
Interventions
radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)
Eligibility Criteria
rectal cancer diagnosed with stage II-IV
You may qualify if:
- Histologically verified rectal carcinoma
- Locally advanced tumor (cT3-4 and/or N+ by transrectal ultrasound and/or pelvic magnetic resonance imaging)
- the distance from anal verge \<= 12cm
- with or without metastasis
- Age 18-75 years old
- ECOG PS 0-2
- No previous chemotherapy or radiotherapy for rectal carcinoma
- Written informed consent
You may not qualify if:
- no histologically verified rectal carcinoma
- rectal cancer with stage I
- distance from verge \>12cm
- age \<=18 or \>=75 years old
- performed previously chemotherapy or radiotherapy
- infection diseases within three months
- serious other diseases
- no written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, China, 200032, China
Related Links
Biospecimen
whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of radiotherapy department in Fudan university shanghai cancer center
Study Record Dates
First Submitted
July 19, 2012
First Posted
August 24, 2012
Study Start
February 1, 2012
Study Completion
February 1, 2013
Last Updated
August 24, 2012
Record last verified: 2012-08