DOD Long-Term Survivors of Ovarian Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | September 2019 |
| Contact: | Giulia Fulci, PhD |
| Email: | gfulci@partners.org |
| Phone: | 617-643-5130 |
The Genomic, Epigenomic, and Psychosocial Characteristics of Long-Term Survivors of Ovarian Cancer - Recruitment
: Stages III and IV serum ovarian cancer are the most lethal of all gynecologic cancers;
however, some advanced-stage ovarian cancer patients are long-term survivors. These patients
may provide the key to long-term survival and bring hope to all women with Stages III and IV
ovarian cancer. There is no meaningful explanation of why some patients with ovarian cancer
become long-term survivors and what their quality of life is long after their initial
diagnosis. This research project will specifically determine molecular features within
tumors along with genetic, quality of life, and lifestyle features that predict for
long-term survival for patients with Stages III and IV ovarian cancer. It will bring
together sophisticated molecular techniques, researchers with longstanding interest, a wide
spectrum of consumer advocates (a number being long-term survivors), and quality of life
experts to analyze the most carefully maintained patient database in the world—the
Gynecologic Oncology Group database. We anticipate the results from this project will
identify specific biochemical pathways and genetic features associated with long-term
survival that can be used to improve the treatment, survival, and survivorship of patients
with this disease. There is clearly something unique among patients who survive Stage III or
IV ovarian cancer long term, and we believe that when we understand what this is, we can
increase the number of long- and longer-term survivors.
however, some advanced-stage ovarian cancer patients are long-term survivors. These patients
may provide the key to long-term survival and bring hope to all women with Stages III and IV
ovarian cancer. There is no meaningful explanation of why some patients with ovarian cancer
become long-term survivors and what their quality of life is long after their initial
diagnosis. This research project will specifically determine molecular features within
tumors along with genetic, quality of life, and lifestyle features that predict for
long-term survival for patients with Stages III and IV ovarian cancer. It will bring
together sophisticated molecular techniques, researchers with longstanding interest, a wide
spectrum of consumer advocates (a number being long-term survivors), and quality of life
experts to analyze the most carefully maintained patient database in the world—the
Gynecologic Oncology Group database. We anticipate the results from this project will
identify specific biochemical pathways and genetic features associated with long-term
survival that can be used to improve the treatment, survival, and survivorship of patients
with this disease. There is clearly something unique among patients who survive Stage III or
IV ovarian cancer long term, and we believe that when we understand what this is, we can
increase the number of long- and longer-term survivors.
Background: Ovarian cancer (OC) remains a major health problem in the United Sates (US). In
2012, there will be an estimated 22,280 cases of epithelial OC (EOC) resulting in 15,500
deaths. While the median survival of OC patients has improved over the last two decades, the
vast majority of patients suffer relapse and develop chemo-resistant disease. The overall
survival of patients suffering from OC has not changed appreciably over the last three
decades. Despite these dismal statistics, there is a minority of OC patients who are
long-term (LT) survivors (>10 years). This includes a subset of advanced stage (~15%) and a
higher proportion of early-stage disease (75%). Unfortunately, there is little genomic or
biologic characterization of these tumors, or patient-reported outcomes that characterize LT
survivors. The clinical importance of identifying subsets of patients who may or may not
benefit from therapy, and understanding the biology of their tumors, is significant both
from a patient survival and quality of life (QOL) standpoint. The characterization of LT
survivors of advanced stage OC will potentially identify molecular and clinical pathways
that can be targeted to help women who have shorter survivals. Further, careful
characterization of these patients, including their initial and longitudinal health-related
QOL reports, their response to treatments, and their tumors will provide significant
measures of prognostic factors. Accurate identification of women with high-grade, early
stage OC who will recur will allow for tailoring therapy to only those who will benefit.
Thus, the systematic molecular and patient-reported outcomes evaluation of LT survivors of
OC (both early and advanced stage) will yield data, which can significantly impact the
management of OC patients.
Overall Aim: To characterize the genomic, biologic, and biobehavioral basis for LT survivors
of EOC. We hypothesize that LT survivors of OC have distinct features that distinguish them
from short-term (ST) survivors.
Specific Aims
1. To characterize the genomic, biologic, and immunologic features of tumors from LT
versus ST survivors of advanced stage EOC. We propose to evaluate the genomic features
(copy number variation, miRNA and methylation patterns) in LT (>7 years) versus ST
survivors (<2 years). In addition, all cases will be evaluated for tumor infiltrating
lymphocytes (TILs). Correlations between TILs and genomic parameters will be examined
along with the identification of genomic/immune signatures that predict for LT
survival. This aim leverages ongoing funded projects characterizing the transcriptome
of advanced stage OC using GOG trials.
2. To validate a genomic signature that predicts for recurrence of early-stage, high-grade
EOC. This aim will leverage an ongoing DOD grant (DOD#OC110628; Birrer, PI) generating
a genomic signature (transcriptome) that distinguishes recurrent from non-recurrent
early-stage, high-grade EOC.
3. To determine the extent to which health-related QOL measures, additional
patient-reported outcomes (PROs), and key CTCAE criteria predict LT ovarian cancer
survival.
4. To examine as an exploratory aim, the potential relationship between health-related
QOL, PROs, and key CTCAE criteria with genomic features predicting disease recurrence.
Proposed Consortium: We propose utilizing the Gynecologic Oncology Group (GOG)
infrastructure as the basis for the consortium, supplemented by the addition of research
sites, administrative structure, advisory boards, and biostatistical support. We consider
this to be a major advantage for this proposal in that the de novo creation of a consortium
will not be necessary. GOG is the world's leading clinical trial organization focused on the
prevention, diagnosis, and treatment of gynecologic cancers. GOG includes over 391 medical
institutions participating in GOG clinical trials. As such, these institutions are familiar
with all GOG procedures including the accurate collection of clinical and QOL data and the
procuring and processing of tissue specimens. GOG institutions have extensive infrastructure
in place to conduct large-scale clinical research and will serve as an established network
of key sites for this project.
2012, there will be an estimated 22,280 cases of epithelial OC (EOC) resulting in 15,500
deaths. While the median survival of OC patients has improved over the last two decades, the
vast majority of patients suffer relapse and develop chemo-resistant disease. The overall
survival of patients suffering from OC has not changed appreciably over the last three
decades. Despite these dismal statistics, there is a minority of OC patients who are
long-term (LT) survivors (>10 years). This includes a subset of advanced stage (~15%) and a
higher proportion of early-stage disease (75%). Unfortunately, there is little genomic or
biologic characterization of these tumors, or patient-reported outcomes that characterize LT
survivors. The clinical importance of identifying subsets of patients who may or may not
benefit from therapy, and understanding the biology of their tumors, is significant both
from a patient survival and quality of life (QOL) standpoint. The characterization of LT
survivors of advanced stage OC will potentially identify molecular and clinical pathways
that can be targeted to help women who have shorter survivals. Further, careful
characterization of these patients, including their initial and longitudinal health-related
QOL reports, their response to treatments, and their tumors will provide significant
measures of prognostic factors. Accurate identification of women with high-grade, early
stage OC who will recur will allow for tailoring therapy to only those who will benefit.
Thus, the systematic molecular and patient-reported outcomes evaluation of LT survivors of
OC (both early and advanced stage) will yield data, which can significantly impact the
management of OC patients.
Overall Aim: To characterize the genomic, biologic, and biobehavioral basis for LT survivors
of EOC. We hypothesize that LT survivors of OC have distinct features that distinguish them
from short-term (ST) survivors.
Specific Aims
1. To characterize the genomic, biologic, and immunologic features of tumors from LT
versus ST survivors of advanced stage EOC. We propose to evaluate the genomic features
(copy number variation, miRNA and methylation patterns) in LT (>7 years) versus ST
survivors (<2 years). In addition, all cases will be evaluated for tumor infiltrating
lymphocytes (TILs). Correlations between TILs and genomic parameters will be examined
along with the identification of genomic/immune signatures that predict for LT
survival. This aim leverages ongoing funded projects characterizing the transcriptome
of advanced stage OC using GOG trials.
2. To validate a genomic signature that predicts for recurrence of early-stage, high-grade
EOC. This aim will leverage an ongoing DOD grant (DOD#OC110628; Birrer, PI) generating
a genomic signature (transcriptome) that distinguishes recurrent from non-recurrent
early-stage, high-grade EOC.
3. To determine the extent to which health-related QOL measures, additional
patient-reported outcomes (PROs), and key CTCAE criteria predict LT ovarian cancer
survival.
4. To examine as an exploratory aim, the potential relationship between health-related
QOL, PROs, and key CTCAE criteria with genomic features predicting disease recurrence.
Proposed Consortium: We propose utilizing the Gynecologic Oncology Group (GOG)
infrastructure as the basis for the consortium, supplemented by the addition of research
sites, administrative structure, advisory boards, and biostatistical support. We consider
this to be a major advantage for this proposal in that the de novo creation of a consortium
will not be necessary. GOG is the world's leading clinical trial organization focused on the
prevention, diagnosis, and treatment of gynecologic cancers. GOG includes over 391 medical
institutions participating in GOG clinical trials. As such, these institutions are familiar
with all GOG procedures including the accurate collection of clinical and QOL data and the
procuring and processing of tissue specimens. GOG institutions have extensive infrastructure
in place to conduct large-scale clinical research and will serve as an established network
of key sites for this project.
Inclusion Criteria:
- stage III/IV high grade epithelial ovarian cancer diagnosed at least 10 years ago
Exclusion Criteria:
- early stage, low grade ovarian cancer diagnosed less than 10 years ago
We found this trial at
1
site
Boston, Massachusetts 02114
Phone: 617-643-5130
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