Prognostic Markers of Gynecologic Cancers
| Status: | Recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/5/2018 |
| Start Date: | December 2003 |
| End Date: | January 2020 |
| Contact: | Zhenmin Lei, MD |
| Email: | z0lei001@louisville.edu |
| Phone: | 502-852-5509 |
This proposal seeks to retain "discard" pieces of human gynecologic tissues and "discard"
ascites fluid collected during normal surgical procedures, along with corresponding blood
samples and urine, for research involving prognostic markers of disease/cancer. The specific
aims of the proposal include:
1. To collect "discard" pieces of benign, pre-malignant and malignant gynecologic tissues,
"discard" ascites fluid and, when possible, corresponding blood and urine specimens from
patients undergoing:
1. hysterectomy
2. excisions of cervical dysplasia and/or venereal warts, and
3. therapeutic excisional surgeries to remove gynecologic disease/cancer (uterine,
ovarian and lower female genital tract).
4. paracentesis for the symptomatic relief of ascites fluid accumulation (distention).
2. To collect pre-operative blood and urine from patients along with pre- operative blood
work drawn for clinical evaluation.
3. De-identify the patients from their donated tissue, blood and urine specimens by
assigning a laboratory identification number.
4. Rapidly process and store the collected specimens to preserve biological integrity.
(RNA, DNA and proteins)
5. Collect and record the patient's demographic and medical information into a research
database under the assigned lab number only.
6. Assess the specimens for prognostic markers of gynecologic disease/cancer by molecular
techniques such as DNA arrays,immunohistochemistry and ELISA.
ascites fluid collected during normal surgical procedures, along with corresponding blood
samples and urine, for research involving prognostic markers of disease/cancer. The specific
aims of the proposal include:
1. To collect "discard" pieces of benign, pre-malignant and malignant gynecologic tissues,
"discard" ascites fluid and, when possible, corresponding blood and urine specimens from
patients undergoing:
1. hysterectomy
2. excisions of cervical dysplasia and/or venereal warts, and
3. therapeutic excisional surgeries to remove gynecologic disease/cancer (uterine,
ovarian and lower female genital tract).
4. paracentesis for the symptomatic relief of ascites fluid accumulation (distention).
2. To collect pre-operative blood and urine from patients along with pre- operative blood
work drawn for clinical evaluation.
3. De-identify the patients from their donated tissue, blood and urine specimens by
assigning a laboratory identification number.
4. Rapidly process and store the collected specimens to preserve biological integrity.
(RNA, DNA and proteins)
5. Collect and record the patient's demographic and medical information into a research
database under the assigned lab number only.
6. Assess the specimens for prognostic markers of gynecologic disease/cancer by molecular
techniques such as DNA arrays,immunohistochemistry and ELISA.
During the last two decades, cancer research has shifted from using cell lines and animal
models to directly using human tissue. This is especially true for research focused on
premalignancies for which there are few good animal models. Research utilizing human tissues
and sera not only addresses many issues/questions of medical research that cannot be
evaluated in cell lines and/or in animal models of human disease, but it also provides a
system to test the relevance of these findings to human diseases. Various biologic and
genetic changes that occur in the developmental stages of human neoplasia can be identified
and analyzed using human tissues.
Research using human tissues and sera is making great strides in the effort to define
possible markers of developing neoplasia and will promote the design of targeted cancer
treatments and possible prevention. It is important to link research findings in tissue and
blood specimens to the clinical outcome of patients with malignancy so we can pinpoint when
and where, during the course of cancer development, molecular changes occur.
Many malignancies of the female genital tract may arise in more than one location, either
synchronously or metachronously, giving rise to the concept of a "field" effect of
carcinogenesis. By collecting tissue from multiple epithelial sites (sampled by the
physician) it is possible to compare the molecular changes seen in preinvasive to those that
occur in invasive neoplasia for differential expression profiles of potential markers. If
protein markers are identified in cells present in the diseased tissue we can check the
patient's serum and urine to see if the proteins can be detected. This information will
enable us to screen and possibly identify these protein markers in patient serum and urine to
correlate with the presence of a premalignant or malignant state.
Malignant ascites is excess fluid that accumulates in the space between the membranes lining
the abdomen and abdominal organs, otherwise known as the peritoneal, or abdominal cavity.
Malignant ascites typically occurs because of a disease, infection, or cancer in the
peritoneal cavity that produces excessive fluid. Ascites fluid accumulation is very common in
gynecologic cancers, especially ovarian. If protein markers are identified in the cells
present in the diseased ascites fluid we may be able to correlate these markers with
metastasis of the disease/cancer and possibly help prevent the spread of several gynecologic
cancers.
models to directly using human tissue. This is especially true for research focused on
premalignancies for which there are few good animal models. Research utilizing human tissues
and sera not only addresses many issues/questions of medical research that cannot be
evaluated in cell lines and/or in animal models of human disease, but it also provides a
system to test the relevance of these findings to human diseases. Various biologic and
genetic changes that occur in the developmental stages of human neoplasia can be identified
and analyzed using human tissues.
Research using human tissues and sera is making great strides in the effort to define
possible markers of developing neoplasia and will promote the design of targeted cancer
treatments and possible prevention. It is important to link research findings in tissue and
blood specimens to the clinical outcome of patients with malignancy so we can pinpoint when
and where, during the course of cancer development, molecular changes occur.
Many malignancies of the female genital tract may arise in more than one location, either
synchronously or metachronously, giving rise to the concept of a "field" effect of
carcinogenesis. By collecting tissue from multiple epithelial sites (sampled by the
physician) it is possible to compare the molecular changes seen in preinvasive to those that
occur in invasive neoplasia for differential expression profiles of potential markers. If
protein markers are identified in cells present in the diseased tissue we can check the
patient's serum and urine to see if the proteins can be detected. This information will
enable us to screen and possibly identify these protein markers in patient serum and urine to
correlate with the presence of a premalignant or malignant state.
Malignant ascites is excess fluid that accumulates in the space between the membranes lining
the abdomen and abdominal organs, otherwise known as the peritoneal, or abdominal cavity.
Malignant ascites typically occurs because of a disease, infection, or cancer in the
peritoneal cavity that produces excessive fluid. Ascites fluid accumulation is very common in
gynecologic cancers, especially ovarian. If protein markers are identified in the cells
present in the diseased ascites fluid we may be able to correlate these markers with
metastasis of the disease/cancer and possibly help prevent the spread of several gynecologic
cancers.
Inclusion Criteria:
- all female patients older than 18 years of age who are:
- undergoing hysterectomy
- excisions of cervical dysplasia and/or venereal warts
- therapeutic excisional surgeries for any benign or malignant gynecologic disease
- paracentesis procedure for the symptomatic relief of ascites fluid accumulation
(distention)
Exclusion Criteria:
- women who are pregnant
- women who are HIV or Hepatitis C positive
- women who are enrolled in a current clinical trial utilizing the specimens
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