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CompletedNCT01623258Updated Jun 19, 2012

A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma

An observational study in Colon Cancer, sponsored by Walter Reed Army Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-19.

Sponsored by Walter Reed Army Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
34
Ages
18 Years and older
Sex
All
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Study summary

The objective of this trial is to define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping.

Null hypothesis: There is no difference in the rate of lymph node metastasis between conventional histopathological processing of lymph nodes and SLN mapping with detailed pathologic examination using immunohistochemistry (IHC) in patients undergoing resection of colon carcinoma.

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Conditions studied

  • Colon Cancer

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In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 34 is below the median of 280 across 349 observational studies indexed under Colonic Neoplasms.

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Lead sponsor

Walter Reed Army Medical Center is the lead sponsor of 45 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Up to 150 male or female military healthcare beneficiaries over the age of 18 years presenting at the Walter Reed Army Medical Center (WRAMC) General Surgery clinic with the diagnosis of biopsy-proven, primary, non-metastatic (Clinical Stage I,II or III) colon carcinoma will be enrolled. Subjects with colonic masses clinically consistent with colon cancer, and eventually confirmed by pathology, will also be enrolled.

Inclusion criteria

  1. 18 years of age
  2. Primary, non-metastatic [Stage I, II (localized, node negative), or III (localized, node positive)] colon carcinoma confirmed by tissue biopsy or colon mass clinically consistent with cancer and eventually confirmed by pathology
  3. Palpable mass at time of surgery
  4. Capable of providing informed consent

Exclusion criteria

Exclusion Criteria:

  1. Prior radiation or chemotherapy
  2. Non-palpable colon tumor
  3. Recurrent or Stage IV (metastatic) colon cancer
  4. Unable to give informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
34 participants (actual)

Groups and cohorts

  • Standard of Care

    Standard histopathological evaluation using conventional paraffin embedding, sectioning and hematoxylin and eosin staining and microscopy without sentinel lymph node ultrastaging

  • Research

    SOC with sentinel lymph node analysis

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What researchers measure

Primary outcomes

  1. Define the rate of upstaging of colon carcinoma lymph node metastasis with define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping

    Time frame: 1 day

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Study locations

1 site
  • Walter Reed Army Medical Center
    Washington DC, District of Columbia 20307-5001, United States
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References and documents

Publications

  • Nissan A, Protic M, Bilchik AJ, Howard RS, Peoples GE, Stojadinovic A. United States Military Cancer Institute Clinical Trials Group (USMCI GI-01) randomized controlled trial comparing targeted nodal assessment and ultrastaging with standard pathological evaluation for colon cancer. Ann Surg. 2012 Sep;256(3):412-27. doi: 10.1097/SLA.0b013e31826571c8. PubMed 22871988 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01623258
Lead sponsor
Walter Reed Army Medical Center
Responsible party
Alexander Stojadinovic (Chief, Surgical Oncology, Walter Reed Army Medical Center) — Principal investigator
First posted
Jun 19, 2012
Start date
Dec 2002
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Jun 19, 2012

Study contacts

Alexander Stojadinovic
principal investigator · Walter Reed Army Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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