Clinical trial · Observational

UMCC 003 Cancer-Related Protein Biomarkers in Blood and Tumor Tissue of Patients With Cancer

Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)

NCT00900094CI-TRIAL-00006219IRB 2000-294completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer and blood from healthy participants may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at cancer-related protein biomarkers in the blood and tumor tissue of patients with cancer and in the blood of healthy participants.

Conditions

Conditions (7)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92
Liver Cancer	Malignant Liver Neoplasm	CURATED_EXACT	0.92
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
fluorescence in situ hybridization	Genetic	—	UNRESOLVED
immunohistochemistry staining method	Other	—	UNRESOLVED
laboratory biomarker analysis	Other	—	UNRESOLVED
mass spectrometry	Other	—	UNRESOLVED
polymerase chain reaction	Genetic	—	UNRESOLVED
protein expression analysis	Genetic	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (4)

measure
Identification of tumor antigens that induce a humoral response in cancer patients
measure
Identification of tumor-secreted proteins by special analysis in culture
measure
Tumor-secreted protein expression in tumors and preneoplastic lesions
measure
Potential markers for early detection of cancer

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria (patient):

  * Scheduled to undergo primary surgical resection or first debulking surgery (prior to any anticancer treatment) for suspected or newly diagnosed cancer, including any of the following types:

    * Breast cancer
    * Adenocarcinoma of the colon
    * Adenocarcinoma or squamous cell carcinoma of the esophagus
    * Non-small cell lung cancer
    * Ovarian epithelial adenocarcinoma
  * Metastatic or unresectable cancer, including any of the following types:

    * Breast cancer
    * Adenocarcinoma of the colon
    * Adenocarcinoma or squamous cell carcinoma of the esophagus
    * Hepatoma
    * Non-small cell lung cancer
    * Small cell lung cancer
    * Ovarian epithelial adenocarcinoma
    * Adenocarcinoma of the pancreas
* Meets the following criteria (healthy participant):

  * No chronic disease

    * Healthy participants with a history of cancer must be cancer-free for 5 years (skin cancer or carcinoma in situ of the cervix within the past 5 years allowed)
  * Willing to provide 60 mL of blood
  * Not a blood relative of an eligible and consenting cancer patient

PATIENT CHARACTERISTICS:

* Able to tolerate the removal of 30-60 mL of blood
* No feelings of light-headedness, dizziness, or fainting within the past 2 weeks
* Pulse less than 100 on day of blood draw for study enrollment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 3 weeks since prior chemotherapy or radiotherapy for metastatic or unresectable cancer
* No concurrent chemotherapy
* No concurrent radiotherapy

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jun 1, 2000
Primary completion: Dec 1, 2006
Completion: Oct 1, 2007
First posted: May 12, 2009
Last update posted: Feb 7, 2012
Enrollment: 200 (actual)
Lead sponsor: University of Michigan Rogel Cancer Center OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IV breast cancer, adenocarcinoma of the colon, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer, extensive stage small cell lung cancer, stage IIIC breast cancer, stage IV pancreatic cancer, recurrent breast cancer, recurrent colon cancer, recurrent esophageal cancer, recurrent non-small cell lung cancer, recurrent ovarian epithelial cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma, recurrent small cell lung cancer

Data updated 22 days ago