Cervical CancerNCT00005095
Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
An observational study of Cervical Cancer and Endometrial Cancer, run by Northwestern University at 1 site in United States.
Trial summary
RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer
- What is being tested?
- Ca-125, screening questionnaire administration and Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 6,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women at high risk of ovarian cancer due to family or personal medical history, or a gynecologic abnormality.
DISEASE CHARACTERISTICS:
- Meets one of the following criteria:
- Considered to be at increased risk for developing ovarian cancer, as defined by one of the following:
- Has at least one first-degree relative (mother, sister, or daughter) with ovarian, primary peritoneal, or fallopian tube cancer
- Has at least two first or second degree relatives diagnosed before age 50 with either ovarian, primary peritoneal, fallopian tube, and/or pancreatic cancer who have tested positive for hereditary cancer syndrome that includes an increased risk of gynecologic cancer (e.g., BRCA1/2 or Lynch Syndrome)or have increased risk as deemed by a certified genetic counselor
- A personal or family history of a hereditary cancer syndrome that includes an increased risk of gynecologic cancer
- Increased risk as deemed by a certified genetic counselor
- Undergoing surgery for a gynecologic condition, including any of the following:
- Diagnosis of a reproductive cancer
- Benign gynecological condition (e.g., uterine leiomyomata, endometriosis, pelvic inflammatory disease, or follicular or corpus luteum ovarian cysts)
- Highly suspicious adnexal mass
- Risk-reducing prophylactic oophorectomy
PATIENT CHARACTERISTICS:
Age
- Between the ages of 18 and 80
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Clinical Trials Office - Robert H. Lurie Comprehensive Cancer, 312-695-1301, cancer@northwestern.edu
About this study
Official title: Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study
RATIONALE: To improve strategies for detection and prevention of early-stage disease.
PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
Read the detailed description
OBJECTIVES:
- To identify and develop highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies.
- To identify new prevention approaches and therapies.
- To identify measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer.
OUTLINE: Subjects undergo periodic specimen and data collection for research studies, including molecular, biochemical, functional, and genetic marker studies. Participants may have samples of blood, tissue, or body fluids (such as ascites, pleural fluid or urine), or any combination of the aforementioned samples obtained to develop tumor markers to detect early stage or recurrent ovarian cancer.
The results from the biomarker research studies will not be reported to the patient or the physician. In the future, if any of the experimental tumor markers are found to be effective in detecting early stage ovarian cancer, and the patient's result is abnormal, the patient and physician will be notified.
Subjects may be asked to complete a combination of questionnaires designed to evaluate psychological functioning among women enrolled in a comprehensive ovarian cancer early detection program who are at increased risk for developing disease as compared to women currently diagnosed with ovarian cancer.
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Ovarian Cancer, Sarcoma
- Being tested
- Ca-125, screening questionnaire administration, Surgery
- Keywords
- ovarian epithelial cancer, hereditary breast/ovarian cancer (BRCA1, BRCA2), fallopian tube cancer, ovarian germ cell tumor, ovarian sarcoma, ovarian stromal cancer, endometrial cancer, uterine sarcoma, vaginal cancer, cervical cancer, vulvar cancer, uterine leiomyomata
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome, Ovarian Neoplasms, Sarcoma, Myofibroma, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ca-125Other
Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer.
screening questionnaire administrationOther
Also called Questionnaire
Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected.
SurgeryProcedure or surgery
Also called BSO, fallopian tubes, TAH, hysterectomy, bilateral salpingectomy, STIC
Subjects will be assessed for high risk factors.
| Study group | Role | What they receive |
|---|---|---|
| High Risk for Ovarian Cancer | Women who are at increased risk of ovarian cancer based on family or personal medical history who are participating in the Northwestern Ovarian Cancer Early Detection and Prevention Program clinic. Receives: Other: Ca-125; Other: screening questionnaire administration; Procedure: Surgery | |
| Suspected or diagnosed gynecological condition | Women who are planning to undergo surgery for their gynecological condition | |
| Control Group | Healthy subjects with no history of cancer and at general risk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other
To identify markers to allow for presymptomatic testing for ovarian and other gynecological malignancies
Measured: 1 year
Secondary outcomes (2)
new prevention approaches and therapies for risk assessment
To identify new prevention approaches and therapies by researching and reviewing the risk of developing disease.
Measured: 1 year
The develop of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer
To identify the measurements to improve the quality of life for women at increased risk for developing the disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2000
- Primary completionDec 2030 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lee Shulman, Northwestern University
- Investigators
- Lee P. Shulman, MD, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005095
- Sponsor's protocol ID
- NU 99G8
- Other IDs
- P30CA060553, NU-99G8, NCI-G00-1753
- Status last verified
- Feb 2025
- First submitted
- 6 Apr 2000
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study
- ClinicalTrials.gov ID
- NCT00005095
- Acronym / sponsor ID
- NU 99G8
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Ovarian Cancer, Sarcoma
- Keywords
- ovarian epithelial cancer, hereditary breast/ovarian cancer (BRCA1, BRCA2), fallopian tube cancer, ovarian germ cell tumor, ovarian sarcoma, ovarian stromal cancer, endometrial cancer, uterine sarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2000 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: To improve strategies for detection and prevention of early-stage disease.
PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
Detailed description
OBJECTIVES:
- To identify and develop highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies.
- To identify new prevention approaches and therapies.
- To identify measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer.
OUTLINE: Subjects undergo periodic specimen and data collection for research studies, including molecular, biochemical, functional, and genetic marker studies. Participants may have samples of blood, tissue, or body fluids (such as ascites, pleural fluid or urine), or any combination of the aforementioned samples obtained to develop tumor markers to detect early stage or recurrent ovarian cancer.
The results from the biomarker research studies will not be reported to the patient or the physician. In the future, if any of the experimental tumor markers are found to be effective in detecting early stage ovarian cancer, and the patient's result is abnormal, the patient and physician will be notified.
Subjects may be asked to complete a combination of questionnaires designed to evaluate psychological functioning among women enrolled in a comprehensive ovarian cancer early detection program who are at increased risk for developing disease as compared to women currently diagnosed with ovarian cancer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Risk for Ovarian Cancer | – | Other: Ca-125, Other: screening questionnaire administration, Procedure: SurgeryWomen who are at increased risk of ovarian cancer based on family or personal medical history who are participating in the Northwestern Ovarian Cancer Early Detection and Prevention Program clinic. |
| Suspected or diagnosed gynecological condition | – | –Women who are planning to undergo surgery for their gynecological condition |
| Control Group | – | –Healthy subjects with no history of cancer and at general risk. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women at high risk of ovarian cancer due to family or personal medical history, or a gynecologic abnormality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ca-125Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer. | Other | High Risk for Ovarian Cancer |
| screening questionnaire administrationAlso: QuestionnaireQuestionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected. | Other | High Risk for Ovarian Cancer |
| SurgeryAlso: BSO, fallopian tubes, TAH, hysterectomy, bilateral salpingectomy, STICSubjects will be assessed for high risk factors. | Procedure or surgery | High Risk for Ovarian Cancer |
Primary outcome
The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other
Time frame: 1 year
To identify markers to allow for presymptomatic testing for ovarian and other gynecological malignancies
2 secondary outcomes
new prevention approaches and therapies for risk assessment
Time frame: 1 year
The develop of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Ovarian, Fallopian Tube, and Primary Peritoneal Cancer ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lee P. Shulman, MD study chair
Robert H. Lurie Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Endometrial Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takelia Walker (3125034802, takelia-watson@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.