Ovarian CancerNCT01422265
Patient Reported Symptoms in Ovarian Cancer (PRECISION)
An observational study of Ovarian Cancer, run by Genentech, Inc. at 31 sites in United States.
Trial summary
This multicenter, observational, prospective study will include approximately 20 US-based centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred > 6 months after first-line platinum-based chemotherapy (first… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 56 participants
- Where
- 31 sitesUnited States
- Study dates
- Jun 2011to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with platinum-sensitive ovarian cancer in maintenance phase of second-line treatment
Who may be able to join
- Histologically documented ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma that has recurred > 6 months after platinum-based chemotherapy
- This must be the first recurrence of the epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma
- Are at least two weeks but no more than 3 months after the completion of second-line cytotoxic chemotherapy
- Are currently under observation or being treated with bevacizumab as a second-line maintenance therapy
- Have a valid email address and access to the internet
- Provide voluntary written informed consent
- Speak and read English fluently
Who cannot join
- Current participation in a blinded clinical trial for ovarian cancer treatment. (Participation in a trial involving only supportive care medicines and/or growth factors is acceptable)
- Another primary diagnosis of cancer in a different site
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Study site
Annandale, Virginia, 22003
Study site
Augusta, Georgia, 30912
Study site
Baltimore, Maryland, 21237
Study site
Buffalo, New York, 14263-0001
Study site
Canton, Ohio, 44718
Study site
Chattanooga, Tennessee, 37403
Study site
Cleveland, Ohio, 44106-5067
Study site
Columbus, Ohio, 43212
Study site
Cumberland, Maryland, 21502
Study site
Englewood, Colorado, 80113
Study site
Farmington, Connecticut, 06030
Study site
Goodyear, Arizona, 85338
Study site
Hinsdale, Illinois, 60521
Study site
Indianapolis, Indiana, 46202
Study site
Indianapolis, Indiana, 46260
Study site
Joliet, Illinois, 60435
Study site
Lincoln, Nebraska, 68510
Study site
Missoula, Montana, 59802
Study site
New Britain, Connecticut, 6052
Study site
New York, New York, 10021
Study site
Oklahoma City, Oklahoma, 73104
Study site
Philadelphia, Pennsylvania, 19124
Study site
Phoenix, Arizona, 85013
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Salinas, California, 93901
Study site
Salt Lake City, Utah, 84132-0001
Study site
Skokie, Illinois, 60076
Study site
Tacoma, Washington, 98405
Study site
Tucson, Arizona, 85724
Study site
Watertown, New York, 57201
Study site
Whittier, California, 90603
About this study
Official title: Patient Reported Symptoms in Ovarian Cancer
This multicenter, observational, prospective study will include approximately 20 US-based centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred > 6 months after first-line platinum-based chemotherapy (first recurrence). Patients who have completed second-line chemotherapy and are currently in observation or undergoing bevacizumab maintenance treatment will be eligible to participate in the study.
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression
Measured: Up to 9 months
Secondary outcomes (3)
MDASI-OC Symptom Severity Score
Measured: Up to 9 months
MDASI-OC Symptom Interference Score
Measured: By month 9
HRQoL scores
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422265
- Sponsor's protocol ID
- ML28066
- Other IDs
- 130/070
- Status last verified
- Nov 2016
- First submitted
- 22 Aug 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Symptoms in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01422265
- Acronym / sponsor ID
- ML28066
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Aug 2011 (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.
This multicenter, observational, prospective study will include approximately 20 US-based centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred > 6 months after first-line platinum-based chemotherapy (first recurrence). Patients who have completed second-line chemotherapy and are currently in observation or undergoing bevacizumab maintenance treatment will be eligible to participate in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with platinum-sensitive ovarian cancer in maintenance phase of second-line treatment
Key inclusion criteria (7 listed)
- Histologically documented ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma that has recurred > 6 months after platinum-based chemotherapy
- This must be the first recurrence of the epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma
- Are at least two weeks but no more than 3 months after the completion of second-line cytotoxic chemotherapy
- Are currently under observation or being treated with bevacizumab as a second-line maintenance therapy
- Have a valid email address and access to the internet
Key exclusion criteria (2 listed)
- Current participation in a blinded clinical trial for ovarian cancer treatment. (Participation in a trial involving only supportive care medicines and/or growth factors is acceptable)
- Another primary diagnosis of cancer in a different site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression
Time frame: Up to 9 months
3 secondary outcomes
MDASI-OC Symptom Severity Score
Time frame: Up to 9 months
MDASI-OC Symptom Interference Score
Time frame: By month 9
HRQoL scores
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Genentech, Inc. at 31 sites 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?
The sponsor lists 7 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression (time frame: Up to 9 months). 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 2 Nov 2016.