Colorectal CancerNCT00949312
Studying Lymph Nodes in Patients With Stage II Colon Cancer
An observational study of Colorectal Cancer, run by Saint John's Cancer Institute at 2 sites in United States.
Trial summary
RATIONALE: Diagnostic procedures that look for micrometastases in lymph nodes removed during surgery for colon cancer may help doctors learn the extent of disease. PURPOSE: This phase I trial is studying lymph nodes in patients with stage II colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- RNA marker analysis of lymph node and primary tumors, microarray profiling of primary tumors and reverse transcriptase-polymerase chain reaction of lymph node specimens
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Dec 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From the ambulatory cancer clinic, we will identify 300 stage II colon cancer patients eligible for the study.
Inclusion Criteria: All of the following inclusion criteria must be met in order for the subject to be eligible.
- Subjects must have CC detected by proctosigmoidoscopy, flexible endoscopy, or gastrograffin/barium enema, with no evidence of distant metastases within 8 weeks of enrollment.
- Subjects with CC must have a computerized tomography (CT; at a minimum - spiral (helical) CT with 5-mm contiguous reconstruction algorithms and adequate volume (based on site-specific protocols) of oral and intravenous contrast agents) of the abdomen and pelvis and a chest x-ray or CT of the chest per standard of care, within 8 weeks prior to enrollment to rule out distant metastases. Subjects with preoperative CT scans and testing showing non-specific or non-diagnostic (equivocal) abnormalities may be eligible pending intraoperative exploration.
- Greater than 18 years of age
- Subjects must have a performance status ≤ 2 on the ECOG/Zubrod scale.
- Subject is able to give informed consent, and must be willing to be followed clinically or by phone/email/mail correspondence
- Subject must have a life expectancy of greater than 5 years not including the disease/diagnosis of CC.
- Subject must have clinical assessment conducted by phone unless patients follow up are part of the regular clinical visits.
Exclusion Criteria: Any of the following criteria will exclude the subject from the study.
- Subjects requiring emergent surgery (within 2 hours of presentation) to prevent a life-threatening situation or death such as those with a perforated colon, metabolically significant complete bowel obstruction or massive GI bleeding will be excluded. Subjects who do not require emergent surgery, such as those with occult bleeding or early or partial bowel obstruction will be permitted to enter.
- Subjects with any history of Crohn's disease, chronic ulcerative colitis, or familial polyposis.
- Discovery of distant metastases intra-operatively.
- Subjects with history of another malignancy over the last three years (except for completely resected cervical, skin cancers or in-situ cancers - see Appendix B for a list of exempt cancers).
- Pregnant and/or lactating women. Potentially childbearing subjects (pre-menopausal women) should undergo a pregnancy test within 7 days prior to surgery and after signing consent. Subjects found to be pregnant will be ineligible and withdrawn from the study.
- Subjects should not be participating in another research protocol at the time of enrollment. Participation during follow-up is acceptable.
- Systemic chemotherapy for node negative colon cancer.
- Complete polypectomy by endoscopy
- Less than 12 lymph nodes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Wayne Cancer Institute
Santa Monica, California, 90404
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001
About this study
Official title: Ultrastaging of Early Colon Cancer
RATIONALE: Diagnostic procedures that look for micrometastases in lymph nodes removed during surgery for colon cancer may help doctors learn the extent of disease.
PURPOSE: This phase I trial is studying lymph nodes in patients with stage II colon cancer.
Read the detailed description
OBJECTIVES:
- Determine whether the immunohistochemical and molecular presence of micrometastases in ≥ 12 lymph nodes removed during en-bloc resection in patients with stage II colon cancer correlates with 3-year disease-free survival.
- Evaluate the prognostic significance of molecular markers detected in the primary tumor and develop a microarray-based gene signature for stage II colon cancer.
OUTLINE: This is a multicenter study.
Tumor tissue and regional lymph node samples are collected during surgery for analysis of micrometastases and molecular markers by immunohistochemistry, qRT-PCR, MM qRT-PCR, qRDNA-PCR, and microarray profiling.
Patients are followed up periodically for 4 years after surgery.
- Conditions
- Colorectal Cancer
- Being tested
- RNA marker analysis of lymph node and primary tumors, microarray profiling of primary tumors, reverse transcriptase-polymerase chain reaction of lymph node specimens, diagnostic laboratory RNA and DNA biomarker analysis of primary tumors, regional lymph node dissection
- Keywords
- stage II colon cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA marker analysis of lymph node and primary tumorsGenetic
microarray profiling of primary tumorsGenetic
reverse transcriptase-polymerase chain reaction of lymph node specimensGenetic
diagnostic laboratory RNA and DNA biomarker analysis of primary tumorsOther
regional lymph node dissectionProcedure or surgery
lymph node staining for H&E and pancytokeratin IHCOther
| Study group | Role | What they receive |
|---|---|---|
| Stage II unresected Colon Cancer | Not described Receives: Genetic: RNA marker analysis of lymph node and primary tumors; Genetic: microarray profiling of primary tumors; Genetic: reverse transcriptase-polymerase chain reaction of lymph node specimens; Other: diagnostic laboratory RNA and DNA biomarker analysis of primary tumors; Procedure: regional lymph node dissection; Other: lymph node staining for H&E and pancytokeratin IHC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (time to local or distant recurrence after resection)
The event to be used for DFS is time to recurrence (local or distant) after resection of colon cancer
Measured: 48 months
Secondary outcomes (1)
Overall survival (time to death from colorectal cancer)
The event to be used for DFS is time to death after resection of colon cancer
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anton J. Bilchik, MD, PhD, FACS, Principal investigator, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949312
- Sponsor's protocol ID
- CDR0000649763
- Other IDs
- UCLA-0809064, BILA-UECC-0107, IRB# 08-09-064-02
- Status last verified
- Mar 2022
- First submitted
- 29 Jul 2009
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Protic M, Stojadinovic A, Nissan A, Wainberg Z, Steele SR, Chen DC, Avital I, Bilchik AJ. Prognostic Effect of Ultra-Staging Node-Negative Colon Cancer Without Adjuvant Chemotherapy: A Prospective National Cancer Institute-Sponsored Clinical Trial. J Am Coll Surg. 2015 Sep;221(3):643-51; quiz 783-5. doi: 10.1016/j.jamcollsurg.2015.05.007. Epub 2015 May 18.
PubMed 26213360
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrastaging of Early Colon Cancer
- ClinicalTrials.gov ID
- NCT00949312
- Acronym / sponsor ID
- CDR0000649763
- Conditions
- Colorectal Cancer
- Keywords
- stage II colon cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2009 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Jul 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: Diagnostic procedures that look for micrometastases in lymph nodes removed during surgery for colon cancer may help doctors learn the extent of disease.
PURPOSE: This phase I trial is studying lymph nodes in patients with stage II colon cancer.
Detailed description
OBJECTIVES:
- Determine whether the immunohistochemical and molecular presence of micrometastases in ≥ 12 lymph nodes removed during en-bloc resection in patients with stage II colon cancer correlates with 3-year disease-free survival.
- Evaluate the prognostic significance of molecular markers detected in the primary tumor and develop a microarray-based gene signature for stage II colon cancer.
OUTLINE: This is a multicenter study.
Tumor tissue and regional lymph node samples are collected during surgery for analysis of micrometastases and molecular markers by immunohistochemistry, qRT-PCR, MM qRT-PCR, qRDNA-PCR, and microarray profiling.
Patients are followed up periodically for 4 years after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage II unresected Colon Cancer | – | Genetic: RNA marker analysis of lymph node and primary tumors, Genetic: microarray profiling of primary tumors, Genetic: reverse transcriptase-polymerase chain reaction of lymph node specimens, Other: diagnostic laboratory RNA and DNA biomarker analysis of primary tumors, Procedure: regional lymph node dissection, Other: lymph node staining for H&E and pancytokeratin IHC |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From the ambulatory cancer clinic, we will identify 300 stage II colon cancer patients eligible for the study.
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 |
|---|---|---|
| RNA marker analysis of lymph node and primary tumors | Genetic | Stage II unresected Colon Cancer |
| microarray profiling of primary tumors | Genetic | Stage II unresected Colon Cancer |
| reverse transcriptase-polymerase chain reaction of lymph node specimens | Genetic | Stage II unresected Colon Cancer |
| diagnostic laboratory RNA and DNA biomarker analysis of primary tumors | Other | Stage II unresected Colon Cancer |
| regional lymph node dissection | Procedure or surgery | Stage II unresected Colon Cancer |
| lymph node staining for H&E and pancytokeratin IHC | Other | Stage II unresected Colon Cancer |
Primary outcome
Disease-free survival (time to local or distant recurrence after resection)
Time frame: 48 months
The event to be used for DFS is time to recurrence (local or distant) after resection of colon cancer
1 secondary outcome
Overall survival (time to death from colorectal cancer)
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 26213360Protic M, Stojadinovic A, Nissan A, Wainberg Z, Steele SR, Chen DC, Avital I, Bilchik AJ. Prognostic Effect of Ultra-Staging Node-Negative Colon Cancer Without Adjuvant Chemotherapy: A Prospective National Cancer Institute-Sponsored Clinical Trial. J Am Coll Surg. 2015 Sep;221(3):643-51; quiz 783-5. doi: 10.1016/j.jamcollsurg.2015.05.007. Epub 2015 May 18.
- Individual participant dataSharing planned: Undecided
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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.
Anton J. Bilchik, MD, PhD, FACS principal investigator
Saint John's Cancer Institute
2 sites 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 Saint John's Cancer Institute at 2 sites 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?
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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
Disease-free survival (time to local or distant recurrence after resection) (time frame: 48 months). 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 NCT00949312, 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 9 Mar 2022.