Prospective Database of Clinical Characteristics and Outcomes For Surgical Oncology Patients

Study ID
STU 092010-072

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • UT Southwestern University Hospital—St. Paul
  • UT Southwestern University Hospital– Zale Lipshy
  • Parkland Health & Hospital System

Contact
Catherine McGilvray
214-648-5826
catherine.mcgilvray@utsouthwestern.edu

Principal Investigator
John Mansour

Summary

all patients seen in the Division of Surgical oncology clinics at the university of Texas Southwestern Medical Center at Dallas and Parkland Health and Hospital System will be eligible for enrollment. Patients consenting to participate in this research will be prospectively entered into an electronic database by either study investigators or the research coordinator.

in addition we would like to also conduct a retrospective and prospective chart review as described below:

Retrospective Review:
The investigators will perform a review of the clinical information systems at Parkland Hospital and the university of Texas Southwestern Medical Center from January 1, 1990 until December 3, 2010. using operative records, the investigators will identify patients undergoing operative intervention with a preoperative or postoperative diagnosis of gastrointestinal or soft-tissue malignancy.

Prospective Chart Review:
The investigators will periodically perform a review of the clinical information systems at Parkland Hospital and the university of Texas Southwestern Medical Center of patients meeting eligibility criteria and were not able to obtain written informed consent due to disparate sites of entry into the clinical health system, the time interval since operation for many of these patients, and the significant mortality associated with the malignancies. once the data is obtained, the Research Coordinator will cross-reference the data and remove any individual who was approached during their clinic visit and declined participation. The information being obtained is routine information commonly recorded in the medical record during a clinical encounter, as outlined in appendix a of the Protocol. additional data fields may be collected during the course of clinical management.

There is no predefined limitation to the number of patients or end date for patients to be included in this investigation.

Participant Eligibility

All new patients in the Division of Surgical Oncology clinics at the University of Texas Southwestern Medical Center at Dallas and Parkland Health and Hospital System with gastrointestinal or soft tissue tumors or conditions resembling these tumors in terms of their presentation, treatment, or natural history will be considered for prospective enrollment. Patients do not need to have a biopsy-confirmed diagnosis of malignancy to be eligible for this protocol. Spanish speaking participants are eligible to participate in this study.

For the clinical information systems review, patients aged 18 years or older with a proven or suspected diagnosis of gastrointestinal or soft-tissue malignancy included in the operative databases of Parkland Health and Hospital System and UTSW will be included. Malignancies will include cancers of the esophagus, stomach, small intestine, pancreas, liver, gallbladder, biliary tract, colon, appendix, peritoneum, rectum, anal canal, extremity and retroperitoneal sarcoma, and melanoma.