Colorectal CancerIMMC-06NCT00133913
Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer
An observational study of Colorectal Cancer and Neoplasm Metastasis, run by Immunicon at 1 site in United States.
Trial summary
This study enrolled patients with measurable metastatic colorectal cancer. Blood was drawn prior to the patient receiving a new therapy for his/her cancer and subsequently at 7-14 days, 3-4 weeks, and when an imaging study was done (~every 6 to 12 weeks). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Neoplasm Metastasis
- What is being tested?
- Phlebotomy
- Type of treatment
- Surgery or procedure
- How many people
- 486 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jan 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncology patients from academic institutions and private practices
Who may be able to join
- Measurable metastatic carcinoma of the colon or rectum.
- 1st or 2nd line chemotherapy (3rd line acceptable with epidermal growth factor receptor [EGFR] targeted therapy)
- Chest/abdomen/pelvis scans every 6-12 weeks
- ECOG 0-2
- Hemoglobin (Hgb) > or = 8g/dl within 7 days prior to enrollment
- Age > or = to 18 years of age
Who cannot join
- Cumulative weekly blood draws exceeding 150mL/week
- Brain metastasis
- Prior history of other carcinoma within the last 5 years, except ductal carcinoma in situ (DCIS), non-invasive cervical cancer or non-melanoma skin cancer
- Surgery within 14 days of the initial blood draw, excluding surgical placement of a central venous device
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Longitudinal Enumeration of Circulating Tumor Cells in Patients With Metastatic Colorectal Carcinomas
This study enrolled patients with measurable metastatic colorectal cancer. Blood was drawn prior to the patient receiving a new therapy for his/her cancer and subsequently at 7-14 days, 3-4 weeks, and when an imaging study was done (~every 6 to 12 weeks). The blood was tested to find circulating tumor cells (CTCs) and to count them. The CTC levels were compared to the imaging study results to see if the CTC number and the imaging result (progression/no progression) were in agreement. Maximum active study participation was 12 months with up to 8 blood draws being taken. All patients are currently being followed for up to 24 months from their off study date for survival. The CTC result will also be used to see if there is a difference in survival and progression-free survival for those patients with and without a certain number of CTCs.
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Being tested
- Phlebotomy
- Keywords
- metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlebotomyProcedure or surgery
Peripheral blood draws for testing of circulating tumor cells
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patients with measurable metastatic colorectal cancer about to start a new line of chemotherapy. Receives: Procedure: Phlebotomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startMar 2004
- Primary completionJan 2007
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunicon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Cohen, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133913
- Sponsor's protocol ID
- IMMC-06
- Acronym
- IMMC-06
- Status last verified
- Mar 2008
- First submitted
- 22 Aug 2005
- Last updated
- 19 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen SJ, Alpaugh RK, Gross S, O'Hara SM, Smirnov DA, Terstappen LW, Allard WJ, Bilbee M, Cheng JD, Hoffman JP, Lewis NL, Pellegrino A, Rogatko A, Sigurdson E, Wang H, Watson JC, Weiner LM, Meropol NJ. Isolation and characterization of circulating tumor cells in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2006 Jul;6(2):125-32. doi: 10.3816/CCC.2006.n.029.
PubMed 16945168Coumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res. 2012 Oct 15;18(20):5711-8. doi: 10.1158/1078-0432.CCR-12-1585. Epub 2012 Sep 25.
PubMed 23014524
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Enumeration of Circulating Tumor Cells in Patients With Metastatic Colorectal Carcinomas
- ClinicalTrials.gov ID
- NCT00133913
- Acronym / sponsor ID
- IMMC-06 / IMMC-06
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Keywords
- metastatic colorectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 486 participants (actual)
- Lead sponsor
- ImmuniconIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2009 (estimated)
- First posted
- 24 Aug 2005 (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.
This study enrolled patients with measurable metastatic colorectal cancer. Blood was drawn prior to the patient receiving a new therapy for his/her cancer and subsequently at 7-14 days, 3-4 weeks, and when an imaging study was done (~every 6 to 12 weeks). The blood was tested to find circulating tumor cells (CTCs) and to count them. The CTC levels were compared to the imaging study results to see if the CTC number and the imaging result (progression/no progression) were in agreement. Maximum active study participation was 12 months with up to 8 blood draws being taken. All patients are currently being followed for up to 24 months from their off study date for survival. The CTC result will also be used to see if there is a difference in survival and progression-free survival for those patients with and without a certain number of CTCs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Procedure: PhlebotomyPatients with measurable metastatic colorectal cancer about to start a new line of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncology patients from academic institutions and private practices
Key inclusion criteria (6 listed)
- Measurable metastatic carcinoma of the colon or rectum.
- 1st or 2nd line chemotherapy (3rd line acceptable with epidermal growth factor receptor [EGFR] targeted therapy)
- Chest/abdomen/pelvis scans every 6-12 weeks
- ECOG 0-2
- Hemoglobin (Hgb) > or = 8g/dl within 7 days prior to enrollment
Key exclusion criteria (4 listed)
- Cumulative weekly blood draws exceeding 150mL/week
- Brain metastasis
- Prior history of other carcinoma within the last 5 years, except ductal carcinoma in situ (DCIS), non-invasive cervical cancer or non-melanoma skin cancer
- Surgery within 14 days of the initial blood draw, excluding surgical placement of a central venous device
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 |
|---|---|---|
| PhlebotomyPeripheral blood draws for testing of circulating tumor cells | Procedure or surgery | Cohort |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2008.
- Background: PubMed 16945168Cohen SJ, Alpaugh RK, Gross S, O'Hara SM, Smirnov DA, Terstappen LW, Allard WJ, Bilbee M, Cheng JD, Hoffman JP, Lewis NL, Pellegrino A, Rogatko A, Sigurdson E, Wang H, Watson JC, Weiner LM, Meropol NJ. Isolation and characterization of circulating tumor cells in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2006 Jul;6(2):125-32. doi: 10.3816/CCC.2006.n.029.
- Derived from this study: PubMed 23014524Coumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res. 2012 Oct 15;18(20):5711-8. doi: 10.1158/1078-0432.CCR-12-1585. Epub 2012 Sep 25.
- 510(k) Premarket NotificationLink provided by the sponsor.
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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.
Steven Cohen, MD principal investigator
Fox Chase Cancer Center
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 and Neoplasm Metastasis, run by Immunicon at 1 site in United States.
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 4 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 19 Mar 2008. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00133913, which also lists 2 linked publications.
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 19 Mar 2008.