New Strategies to Assess Anal Cancer Risk In Women
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/7/2018 |
| Start Date: | July 2016 |
| End Date: | December 31, 2019 |
The purpose of this research is to study different strategies to identify women at highest
risk for anal cancer. Primarily, investigators want to study a risk assessment called the
Anal Cancer Risk Index; it gives women an overall number score based on risk factors that
they may have for anal cancer, such as age, number of sexual partners, or smoking.
Investigators seek to understand whether women with higher Anal Cancer Risk Index scores are
more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. The
study team will collect swabs of the cervix and the anus to study different laboratory tests
that could identify women at highest risk of cervical and anal cancer. These laboratory tests
include an anal pap smear, tests for markers of disease and tests that detect the HPV types
most likely to cause cancer. The study team would like to see which of these laboratory tests
do the best job at predicting precancerous lesions in the anus and are better indicators of
risk for cancer. After collecting these swabs, women will have a procedure called high
resolution anoscopy where investigators look closely at the anus and biopsy any suspicious
areas. Finally, the study team will look for HPV proteins and changes that HPV can make in
cells to see if these tests predict anal lesions.
risk for anal cancer. Primarily, investigators want to study a risk assessment called the
Anal Cancer Risk Index; it gives women an overall number score based on risk factors that
they may have for anal cancer, such as age, number of sexual partners, or smoking.
Investigators seek to understand whether women with higher Anal Cancer Risk Index scores are
more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. The
study team will collect swabs of the cervix and the anus to study different laboratory tests
that could identify women at highest risk of cervical and anal cancer. These laboratory tests
include an anal pap smear, tests for markers of disease and tests that detect the HPV types
most likely to cause cancer. The study team would like to see which of these laboratory tests
do the best job at predicting precancerous lesions in the anus and are better indicators of
risk for cancer. After collecting these swabs, women will have a procedure called high
resolution anoscopy where investigators look closely at the anus and biopsy any suspicious
areas. Finally, the study team will look for HPV proteins and changes that HPV can make in
cells to see if these tests predict anal lesions.
Investigators seek to study different strategies to identify women at highest risk for anal
cancer. Primarily, investigators want to study a risk assessment called the Anal Cancer Risk
Index; it gives women an overall number score based on risk factors that they may have for
anal cancer, such as age, number of sexual partners, or smoking. The study team would like to
determine whether women with higher Anal Cancer Risk Index scores are more likely to have
abnormal results on anal pap smears, HPV tests, or anal biopsies. Next, the team will collect
a swab of the cervix and swabs of the anus to study different laboratory tests that could
identify women at highest risk of anal cancer: these tests include an anal pap smear and
tests that detect HPV types most likely to cause cancer. Investigators would like to see
which of these laboratory tests do the best job at predicting precancerous lesions in the
anus. After collecting these swabs, women will have a procedure called high resolution
anoscopy where investigators will look closely at the anus and biopsy any suspicious areas.
Finally, the study team will look for HPV proteins and changes that HPV can make in cells to
see if these tests predict anal lesions. The HPV protein is called E6 and E7 and the cell
change test is called CADM1/MAL/miR-124-2. Investigators will measure E6/E7 and
CADM1/MAL/miR-124-2 in cervical and anal samples to see if women positive for this marker are
more likely to have abnormal results on anal pap smears or anal biopsies.
cancer. Primarily, investigators want to study a risk assessment called the Anal Cancer Risk
Index; it gives women an overall number score based on risk factors that they may have for
anal cancer, such as age, number of sexual partners, or smoking. The study team would like to
determine whether women with higher Anal Cancer Risk Index scores are more likely to have
abnormal results on anal pap smears, HPV tests, or anal biopsies. Next, the team will collect
a swab of the cervix and swabs of the anus to study different laboratory tests that could
identify women at highest risk of anal cancer: these tests include an anal pap smear and
tests that detect HPV types most likely to cause cancer. Investigators would like to see
which of these laboratory tests do the best job at predicting precancerous lesions in the
anus. After collecting these swabs, women will have a procedure called high resolution
anoscopy where investigators will look closely at the anus and biopsy any suspicious areas.
Finally, the study team will look for HPV proteins and changes that HPV can make in cells to
see if these tests predict anal lesions. The HPV protein is called E6 and E7 and the cell
change test is called CADM1/MAL/miR-124-2. Investigators will measure E6/E7 and
CADM1/MAL/miR-124-2 in cervical and anal samples to see if women positive for this marker are
more likely to have abnormal results on anal pap smears or anal biopsies.
Inclusion Criteria:
- Currently enrolled in the Women's HIV Interagency Study (WIHS) study
- Able and willing to undergo anal cytology, anal molecular testing, and high resolution
anoscopy with targeted anal biopsies
Exclusion Criteria:
- History of high grade anal intraepithelial neoplasia (AIN 2 or 3)
- History of active anal disease requiring surgery
- History of anal or cervical cancer
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