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BRIEF TITLE: Immunopheotype of Locally Advanced Rectal Adenocarcinoma and Its Correlation With the Efficacy of Neoadjuvant Chemoradiotherapy

A Study to Determine the Immunopheotype of Locally Advanced Rectal Adenocarcinoma and Its Correlation With the Efficacy of Neoadjuvant Chemoradiotherapy


  • Org Study ID: 13-107A
  • Secondary ID:
  • NCT ID: NCT02017509
  • NCT Alias:
  • Sponsor: Providence Health & Services - Other
  • Source: Providence Health & Services

Brief Summary

This is an observational study of tumor samples and MRI imaging in patients with colorectal, melanoma, breast, renal cell, lung, bladder, head and neck, ovarian and thyroid cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment.

Detailed Description


The quality of the immune environment in colorectal cancer biopsy samples correlates with
disease-free survival and overall survival more so than current staging conventions. This
study will use a scoring system called 'immunoscore' to characterize the immune enviroment.
Researchers hypothesize that the immunoscore will correlate with outcomes of colorectal
patients treated with neoadjuvant chemoradiation. Researchers will also collect samples from
melanoma, breast, renal cell, lung, bladder, head and neck, ovarian and thyroid cancers for
exploratory research.

Overal Status Start Date Phase Study Type
Recruiting Start Date: September 2013 N/A Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Correlation of the number of infiltrating leukocytes within a biopsy sample with pathologic response

Primary Outcome 1 - Time Frame: 16 weeks

Condition:

  • Cancer of the Rectum
  • Neoplasms, Rectal
  • Rectal Cancer
  • Rectal Tumors
  • Rectal Adenocarcinoma
  • Melanoma
  • Breast Cancer
  • Renal Cell Cancer
  • Lung Cancer
  • Bladder Cancer
  • Head and Neck Cancer
  • Ovarian Cancer
  • Thyroid Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Patients with a diagnosis of a rectal mass suspicious for or known to be an
adenocarcinoma of the rectum.

- Age > 18

- Ability to give informed consent and comply with the protocol. Patients with a history
of psychiatric illness must be judged able to understand fully the investigational
nature of the study and the risks associated with the therapy.

Exclusion Criteria:

- History of other malignancy in the past 2 years except carcinoma in situ of the cervix
or bladder, or non-melanomatous skin cancer

- Other medical or psychiatric conditions that in the opinion of the Principal
Investigator would preclude safe participation in protocol.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Marka Crittenden, MD, PhD

Role: Principal Investigator

Affiliation: Earle A. Chiles Research Institute at Providence Health & Services

Overall Contact

Name: Marka Crittenden, MD, PhD

Phone: (503) 215-6029

Email: marka.crittenden@providence.org

Link: Providence Cancer Center

Locations

Facility Status Contact
Providence Health & Services
Portland, Oregon 97213
United States
Recruiting
Oregon Health & Science University
Portland, Oregon 97239
United States
Recruiting Kristina Young, MD, PhD
503-418-0990
youngkri@ohsu.edu