Cancer DNA in Blood and Urine
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 11/9/2018 |
| Start Date: | November 2014 |
| End Date: | December 2022 |
Non-invasive Detection of Cancer DNA in Blood and Urine
This study is being conducted to collect and analyze biospecimens (blood and urine) and
clinical data from patients with prostate cancer as well as healthy volunteers to better
understand the differences between cancer cells and normal tissues with the goal of
developing a better way to detect and track the treatment of prostate cancer.
- These samples are being collected to conduct research to accomplish the goal of
improving cancer therapies, biomarkers, and hopefully lead to more effective treatment
of prostate cancer.
- The samples that you are providing as a patient with prostate cancer will be used in
future research.
- Your biospecimens will be compared to the cancer and normal volunteer specimens from
other participants to understand genetic differences between normal and cancer cells.
Genetic material, including DNA and RNA, will be obtained from samples, stored, and used
for evaluation.
- Clinical information and samples will be collected and stored for ongoing research. This
is a necessity because improved diagnosis, prognosis and treatment of cancer in the
future depend upon the ongoing analysis of basic research findings and clinical
outcomes. This type of research may improve the lives of future patients with cancer.
Men between the ages of 18 and 100 with a diagnosis of cancer undergoing standard therapy
with radiation may join.
clinical data from patients with prostate cancer as well as healthy volunteers to better
understand the differences between cancer cells and normal tissues with the goal of
developing a better way to detect and track the treatment of prostate cancer.
- These samples are being collected to conduct research to accomplish the goal of
improving cancer therapies, biomarkers, and hopefully lead to more effective treatment
of prostate cancer.
- The samples that you are providing as a patient with prostate cancer will be used in
future research.
- Your biospecimens will be compared to the cancer and normal volunteer specimens from
other participants to understand genetic differences between normal and cancer cells.
Genetic material, including DNA and RNA, will be obtained from samples, stored, and used
for evaluation.
- Clinical information and samples will be collected and stored for ongoing research. This
is a necessity because improved diagnosis, prognosis and treatment of cancer in the
future depend upon the ongoing analysis of basic research findings and clinical
outcomes. This type of research may improve the lives of future patients with cancer.
Men between the ages of 18 and 100 with a diagnosis of cancer undergoing standard therapy
with radiation may join.
The American Cancer Society estimates that approximately 29,480 men will die of prostate
cancer in the United States in 2014. Many of these men were initially diagnosed with
aggressive prostate cancer (so-called "high risk" prostate cancer), often with cancer that
extended beyond the prostate gland itself or was of a high Gleason score, or was associated
with a Prostate Specific Antigen [PSA] level > 20 ng/ml. In contrast to the more favorable
outcomes in men with low and intermediate risk disease, nearly 50% of men with high-risk
prostate cancer will have a recurrence of their cancer despite a complete course of
treatment. One of the mainstays of care for men with high-risk prostate cancer is a
combination of radiation therapy and hormone suppression (more appropriately called androgen
deprivation [ADT]). Despite advances, a clear need exists for improved clinical management of
high risk disease.
One of the challenges in the overall management of men with high risk prostate cancer is the
lack of a reliable test allowing clinicians to monitor tumor response both during and after
radiation therapy. The commonly used marker, prostate specific antigen (PSA), is less useful
in men receiving ADT. In these men, the PSA is level is strongly suppressed by the ADT and is
a less reliable surrogate for detecting active tumor. Importantly, ADT is given both during
and for up to 3 years following radiation therapy, limiting the utility of PSA testing for an
extended period of time during which the window for curative therapies may close. The
development of an accurate, noninvasive monitoring test is needed, to guide early
implementation of salvage strategies aimed at increasing the proportion of patients cured of
their disease.
Prior research from our group and several others has demonstrated that prostate cancers
nearly universally harbor stable, cancer-specific changes (modifications) of the DNA.
Furthermore, published studies have shown that this modified (methylated) DNA can be readily
detected in urine and blood specimens from men with primary prostate cancer.
Investigators hypothesize that large scale assessment of cancer-specific DNA changes and
rearrangements in the urine and plasma of prostate cancer patients using technology developed
by our group (qMBD-seq), will allow for more informative and accurate tracking of disease
burden and therapeutic response in men receiving radiation therapy and ADT for high-risk
prostate cancer.
Investigators have two straightforward primary objectives for this pilot study. First we will
establish the background levels of modified DNA in individuals with no history of prostate
cancer. Second, investigators will quantify cancer-specific methylated DNA in men with known
high risk prostate cancer. Investigators will begin by collecting urine and plasma specimens
from normal volunteers. In parallel investigators will collect specimens for quantitation of
cancer-specific DNA modifications in men with known high-risk prostate cancer receiving
standard treatment in the Department of Radiation Oncology. Patient samples will be collected
at multiple time points before, during, and after radiation treatment and then will be
subjected to careful DNA sequencing and analysis. This will allow investigators to
simultaneously characterize and quantify prostate cancer specific DNA occurring anywhere in
the genome, thereby allowing investigators to predict which patients have prostate cancer
still present in their body after treatment even if the PSA is very low or undetectable. If
successful, this project will be an important first step in the development of a noninvasive
test to track disease burden and therapeutic response during and after radiation therapy for
high-risk prostate cancer.
cancer in the United States in 2014. Many of these men were initially diagnosed with
aggressive prostate cancer (so-called "high risk" prostate cancer), often with cancer that
extended beyond the prostate gland itself or was of a high Gleason score, or was associated
with a Prostate Specific Antigen [PSA] level > 20 ng/ml. In contrast to the more favorable
outcomes in men with low and intermediate risk disease, nearly 50% of men with high-risk
prostate cancer will have a recurrence of their cancer despite a complete course of
treatment. One of the mainstays of care for men with high-risk prostate cancer is a
combination of radiation therapy and hormone suppression (more appropriately called androgen
deprivation [ADT]). Despite advances, a clear need exists for improved clinical management of
high risk disease.
One of the challenges in the overall management of men with high risk prostate cancer is the
lack of a reliable test allowing clinicians to monitor tumor response both during and after
radiation therapy. The commonly used marker, prostate specific antigen (PSA), is less useful
in men receiving ADT. In these men, the PSA is level is strongly suppressed by the ADT and is
a less reliable surrogate for detecting active tumor. Importantly, ADT is given both during
and for up to 3 years following radiation therapy, limiting the utility of PSA testing for an
extended period of time during which the window for curative therapies may close. The
development of an accurate, noninvasive monitoring test is needed, to guide early
implementation of salvage strategies aimed at increasing the proportion of patients cured of
their disease.
Prior research from our group and several others has demonstrated that prostate cancers
nearly universally harbor stable, cancer-specific changes (modifications) of the DNA.
Furthermore, published studies have shown that this modified (methylated) DNA can be readily
detected in urine and blood specimens from men with primary prostate cancer.
Investigators hypothesize that large scale assessment of cancer-specific DNA changes and
rearrangements in the urine and plasma of prostate cancer patients using technology developed
by our group (qMBD-seq), will allow for more informative and accurate tracking of disease
burden and therapeutic response in men receiving radiation therapy and ADT for high-risk
prostate cancer.
Investigators have two straightforward primary objectives for this pilot study. First we will
establish the background levels of modified DNA in individuals with no history of prostate
cancer. Second, investigators will quantify cancer-specific methylated DNA in men with known
high risk prostate cancer. Investigators will begin by collecting urine and plasma specimens
from normal volunteers. In parallel investigators will collect specimens for quantitation of
cancer-specific DNA modifications in men with known high-risk prostate cancer receiving
standard treatment in the Department of Radiation Oncology. Patient samples will be collected
at multiple time points before, during, and after radiation treatment and then will be
subjected to careful DNA sequencing and analysis. This will allow investigators to
simultaneously characterize and quantify prostate cancer specific DNA occurring anywhere in
the genome, thereby allowing investigators to predict which patients have prostate cancer
still present in their body after treatment even if the PSA is very low or undetectable. If
successful, this project will be an important first step in the development of a noninvasive
test to track disease burden and therapeutic response during and after radiation therapy for
high-risk prostate cancer.
Inclusion Criteria:
1. Male older than or equal to 18 years of age, but not older than 100 years of age.
2. Signed informed consent prior to initiation of any study-related procedures.
3. Minorities are included in this protocol.
4. Signed informed consent prior to initiation of any study-related
Exclusion Criteria:
1. It is the enrolling study physician's discretion to decide if a patient is not fit
enough to undergo procedures outlined in this protocol.
2. Persons who are incarcerated are not eligible to participate.
3. Women are not eligible.
4. Persons incapable of providing informed consent are not eligible.
5. Any person with a personal history of prior malignancy is not eligible
6. Persons with an inherited cancer syndrome or a medical history suggestive of an
inherited cancer syndrome are not eligible.
We found this trial at
1
site
Baltimore, Maryland 21287
Principal Investigator: Theodore DeWeese, M.D.
Phone: 410-614-1598
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