CancerLCCM-ControlNCT02261051
Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm
An observational study of Cancer and Advanced Cancer, run by Lancaster General Hospital at 1 site in United States.
Trial summary
Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Advanced Cancer
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Sep 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our study population includes patients newly diagnosed with a solid tumor-type cancer that is considered either advanced and unresectable or metastatic. Patients also will be at least 18 years of age and English-speaking.
Who may be able to join
- Newly diagnosed with a solid tumor-type cancer that is considered either advanced and unresectable or metastatic
Who cannot join
- Non-English speaking
- Age < 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Lancaster General Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania, 17604
About this study
Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study). The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).
Read the detailed description
Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study) that was submitted to the National Cancer Institute (NCI) for funding. A decision on funding the full study should be forthcoming in the early part of 2015. The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. To accomplish the aims of the study by the end of the funding period, we propose to begin data collection in advance of a funding decision. Should the study not receive funding, the data collected will be used to inform decisions regarding other funding applications and/or implementation of program changes at the Ann B. Barshinger Cancer Institute. Data collection does not represent more than minimal risk for the patients enrolled.
This protocol is for the first phase of the study, which is the enrollment and collection of data on the control group, to serve as the baseline for comparison regarding hospitalizations, ED visits, quality of life, and patient and family satisfaction. To achieve sufficient number of subjects and observed deaths in the control group, we are targeting the start of enrollment and data collection in this group during the third quarter of 2014. If the project is funded, the intervention and enrollment in the intervention group are targeted to start in the second quarter of 2016. Background and study aims are presented for the entire project to provide context, but the intent of this application is only for approval of the enrollment and data collection on the control subjects (which contributes to aims 2 and 3 of the larger project). A second protocol would be presented for review and approval at the start of the intervention if the project funding is granted.
In phase one of the project, subjects would be approached and consented at the point of a determination/diagnosis of advanced cancer and followed until the end of life or the start of the intervention period in the 2nd quarter of 2016 (whichever comes first) per protocol.
This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).
- Conditions
- Cancer, Advanced Cancer
- Being tested
- Standard of care
- Keywords
- Palliative Care, Hospice, End of Life, Health Service Utilization, Quality of Life
- Medical subject headings
- Neoplasms, Death, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Patients will be cared for using current standard of care preceding the design and implementation of the LCCM model of care.
| Study group | Role | What they receive |
|---|---|---|
| Non-concurrent control group | A group of advanced cancer patients who received care at our Center before implementation of the LCCM model. They will receive current standard of care.
This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase). Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients' ED visits and hospitalizations
All cause: ED admission treat and release, ED admission to inpatient visit and direct inpatient admission
Measured: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Secondary outcomes (5)
Patient quality of life
Assessed with FACT-G (Functional Assessment of Cancer-General measure)
Measured: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Patient satisfaction
Assessed with FAMCARE-2 (patient and family satisfaction with care)
Measured: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Caregiver burden
Assessed with BASC (Brief Assessment Scale for Caregivers) Caregiver Burden
Measured: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Caregiver satisfaction
Assessed with FAMCARE-2 (patient and family satisfaction with care)
Measured: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Patient symptoms
Assessed with the ESAS-R (Edmonton Symptom Assessment System Revised) and ECOG (Eastern Cooperative Oncology Group) performance status
Measured: Collected at baseline and every outpatient oncology clinic visit from enrollment until death from any cause or assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Difficulty in recruitment and change in study site protocols.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (59)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanthi Sivendran, MD, MSCR, Study director, Lancaster General Ann B. Barshinger Cancer InstituteRandy Oyer, MD, Study director, Lancaster General Ann B. Barshinger Cancer InstituteNik Buescher, Principal investigator, Lancaster General Ann B. Barshinger Cancer InstituteJoan Harrold, MD, Principal investigator, Palliative Medicine ConsultantsBarbara Martin, PhD, Principal investigator, Lancaster General Research InstituteKristina Newport, MD, Principal investigator, Palliative Medicine ConsultantsMichael Horst, PhD, Principal investigator, Lancaster General Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261051
- Sponsor's protocol ID
- 2014-48
- Acronym
- LCCM-Control
- Status last verified
- Apr 2016
- First submitted
- 29 Sep 2014
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Aoun S, Bird S, Kristjanson LJ, Currow D. Reliability testing of the FAMCARE-2 scale: measuring family carer satisfaction with palliative care. Palliat Med. 2010 Oct;24(7):674-81. doi: 10.1177/0269216310373166. Epub 2010 Jul 9.
PubMed 20621947Back AL, Arnold RM, Baile WF, Tulsky JA, Fryer-Edwards K. Approaching difficult communication tasks in oncology. CA Cancer J Clin. 2005 May-Jun;55(3):164-77. doi: 10.3322/canjclin.55.3.164.
PubMed 15890639Baile WF, Lenzi R, Parker PA, Buckman R, Cohen L. Oncologists' attitudes toward and practices in giving bad news: an exploratory study. J Clin Oncol. 2002 Apr 15;20(8):2189-96. doi: 10.1200/JCO.2002.08.004.
PubMed 11956281Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
PubMed 19690306Barnato AE, Llewellyn-Thomas HA, Peters EM, Siminoff L, Collins ED, Barry MJ. Communication and decision making in cancer care: setting research priorities for decision support/patients' decision aids. Med Decis Making. 2007 Sep-Oct;27(5):626-34. doi: 10.1177/0272989X07306788. Epub 2007 Sep 14.
PubMed 17873249Brumley RD, Enguidanos S, Cherin DA. Effectiveness of a home-based palliative care program for end-of-life. J Palliat Med. 2003 Oct;6(5):715-24. doi: 10.1089/109662103322515220.
PubMed 14622451Brumley R, Enguidanos S, Jamison P, Seitz R, Morgenstern N, Saito S, McIlwane J, Hillary K, Gonzalez J. Increased satisfaction with care and lower costs: results of a randomized trial of in-home palliative care. J Am Geriatr Soc. 2007 Jul;55(7):993-1000. doi: 10.1111/j.1532-5415.2007.01234.x.
PubMed 17608870Bull JH, Whitten E, Morris J, Hooper RN, Wheeler JL, Kamal A, Abernethy AP. Demonstration of a sustainable community-based model of care across the palliative care continuum. J Pain Symptom Manage. 2012 Dec;44(6):797-809. doi: 10.1016/j.jpainsymman.2011.12.278. Epub 2012 Jul 7.
PubMed 22771124Carter GL, Lewin TJ, Gianacas L, Clover K, Adams C. Caregiver satisfaction with out-patient oncology services: utility of the FAMCARE instrument and development of the FAMCARE-6. Support Care Cancer. 2011 Apr;19(4):565-72. doi: 10.1007/s00520-010-0858-1. Epub 2010 Mar 28.
PubMed 20349317Cheifetz O, Packham TL, Macdermid JC. Rasch analysis of the Edmonton Symptom Assessment System and research implications. Curr Oncol. 2014 Apr;21(2):e186-94. doi: 10.3747/co.21.1735.
PubMed 24764703Colon M. Hospice and Latinos: a review of the literature. J Soc Work End Life Palliat Care. 2005;1(2):27-43. doi: 10.1300/J457v01n02_04.
PubMed 17387062Conrad KJ, Iris M, Ridings JW, Langley K, Wilber KH. Self-report measure of financial exploitation of older adults. Gerontologist. 2010 Dec;50(6):758-73. doi: 10.1093/geront/gnq054. Epub 2010 Jul 28.
PubMed 20667945Daugherty CK, Hlubocky FJ. What are terminally ill cancer patients told about their expected deaths? A study of cancer physicians' self-reports of prognosis disclosure. J Clin Oncol. 2008 Dec 20;26(36):5988-93. doi: 10.1200/JCO.2008.17.2221. Epub 2008 Nov 24.
PubMed 19029419de Kock I, Mirhosseini M, Lau F, Thai V, Downing M, Quan H, Lesperance M, Yang J. Conversion of Karnofsky Performance Status (KPS) and Eastern Cooperative Oncology Group Performance Status (ECOG) to Palliative Performance Scale (PPS), and the interchangeability of PPS and KPS in prognostic tools. J Palliat Care. 2013 Autumn;29(3):163-9.
PubMed 24380215Degenholtz HB, Thomas SB, Miller MJ. Race and the intensive care unit: disparities and preferences for end-of-life care. Crit Care Med. 2003 May;31(5 Suppl):S373-8. doi: 10.1097/01.CCM.0000065121.62144.0D. No abstract available.
PubMed 12771586
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm
- ClinicalTrials.gov ID
- NCT02261051
- Acronym / sponsor ID
- LCCM-Control / 2014-48
- Conditions
- Cancer, Advanced Cancer
- Keywords
- Palliative Care, Hospice, End of Life, Health Service Utilization, Quality of Life
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty in recruitment and change in study site protocols.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lancaster General HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Oct 2014 (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.
Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study). The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).
Detailed description
Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study) that was submitted to the National Cancer Institute (NCI) for funding. A decision on funding the full study should be forthcoming in the early part of 2015. The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. To accomplish the aims of the study by the end of the funding period, we propose to begin data collection in advance of a funding decision. Should the study not receive funding, the data collected will be used to inform decisions regarding other funding applications and/or implementation of program changes at the Ann B. Barshinger Cancer Institute. Data collection does not represent more than minimal risk for the patients enrolled.
This protocol is for the first phase of the study, which is the enrollment and collection of data on the control group, to serve as the baseline for comparison regarding hospitalizations, ED visits, quality of life, and patient and family satisfaction. To achieve sufficient number of subjects and observed deaths in the control group, we are targeting the start of enrollment and data collection in this group during the third quarter of 2014. If the project is funded, the intervention and enrollment in the intervention group are targeted to start in the second quarter of 2016. Background and study aims are presented for the entire project to provide context, but the intent of this application is only for approval of the enrollment and data collection on the control subjects (which contributes to aims 2 and 3 of the larger project). A second protocol would be presented for review and approval at the start of the intervention if the project funding is granted.
In phase one of the project, subjects would be approached and consented at the point of a determination/diagnosis of advanced cancer and followed until the end of life or the start of the intervention period in the 2nd quarter of 2016 (whichever comes first) per protocol.
This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-concurrent control group | – | Other: Standard of careA group of advanced cancer patients who received care at our Center before implementation of the LCCM model. They will receive current standard of care. This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study population includes patients newly diagnosed with a solid tumor-type cancer that is considered either advanced and unresectable or metastatic. Patients also will be at least 18 years of age and English-speaking.
Key inclusion criteria (1 listed)
- Newly diagnosed with a solid tumor-type cancer that is considered either advanced and unresectable or metastatic
Key exclusion criteria (2 listed)
- Non-English speaking
- Age < 18
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 |
|---|---|---|
| Standard of carePatients will be cared for using current standard of care preceding the design and implementation of the LCCM model of care. | Other | Non-concurrent control group |
Primary outcome
Frequency of patients' ED visits and hospitalizations
Time frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
All cause: ED admission treat and release, ED admission to inpatient visit and direct inpatient admission
5 secondary outcomes
Patient quality of life
Time frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Patient satisfaction
Time frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Caregiver burden
Time frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Caregiver satisfaction
Time frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Patient symptoms
Time frame: Collected at baseline and every outpatient oncology clinic visit from enrollment until death from any cause or assessed up to 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Background: PubMed 20621947Aoun S, Bird S, Kristjanson LJ, Currow D. Reliability testing of the FAMCARE-2 scale: measuring family carer satisfaction with palliative care. Palliat Med. 2010 Oct;24(7):674-81. doi: 10.1177/0269216310373166. Epub 2010 Jul 9.
- Background: PubMed 15890639Back AL, Arnold RM, Baile WF, Tulsky JA, Fryer-Edwards K. Approaching difficult communication tasks in oncology. CA Cancer J Clin. 2005 May-Jun;55(3):164-77. doi: 10.3322/canjclin.55.3.164.
- Background: PubMed 11956281Baile WF, Lenzi R, Parker PA, Buckman R, Cohen L. Oncologists' attitudes toward and practices in giving bad news: an exploratory study. J Clin Oncol. 2002 Apr 15;20(8):2189-96. doi: 10.1200/JCO.2002.08.004.
- Background: PubMed 19690306Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
- Background: PubMed 17873249Barnato AE, Llewellyn-Thomas HA, Peters EM, Siminoff L, Collins ED, Barry MJ. Communication and decision making in cancer care: setting research priorities for decision support/patients' decision aids. Med Decis Making. 2007 Sep-Oct;27(5):626-34. doi: 10.1177/0272989X07306788. Epub 2007 Sep 14.
- Background: PubMed 14622451Brumley RD, Enguidanos S, Cherin DA. Effectiveness of a home-based palliative care program for end-of-life. J Palliat Med. 2003 Oct;6(5):715-24. doi: 10.1089/109662103322515220.
- Background: PubMed 17608870Brumley R, Enguidanos S, Jamison P, Seitz R, Morgenstern N, Saito S, McIlwane J, Hillary K, Gonzalez J. Increased satisfaction with care and lower costs: results of a randomized trial of in-home palliative care. J Am Geriatr Soc. 2007 Jul;55(7):993-1000. doi: 10.1111/j.1532-5415.2007.01234.x.
- Background: PubMed 22771124Bull JH, Whitten E, Morris J, Hooper RN, Wheeler JL, Kamal A, Abernethy AP. Demonstration of a sustainable community-based model of care across the palliative care continuum. J Pain Symptom Manage. 2012 Dec;44(6):797-809. doi: 10.1016/j.jpainsymman.2011.12.278. Epub 2012 Jul 7.
- Background: PubMed 20349317Carter GL, Lewin TJ, Gianacas L, Clover K, Adams C. Caregiver satisfaction with out-patient oncology services: utility of the FAMCARE instrument and development of the FAMCARE-6. Support Care Cancer. 2011 Apr;19(4):565-72. doi: 10.1007/s00520-010-0858-1. Epub 2010 Mar 28.
- Background: PubMed 24764703Cheifetz O, Packham TL, Macdermid JC. Rasch analysis of the Edmonton Symptom Assessment System and research implications. Curr Oncol. 2014 Apr;21(2):e186-94. doi: 10.3747/co.21.1735.
- Background: PubMed 17387062Colon M. Hospice and Latinos: a review of the literature. J Soc Work End Life Palliat Care. 2005;1(2):27-43. doi: 10.1300/J457v01n02_04.
- Background: PubMed 20667945Conrad KJ, Iris M, Ridings JW, Langley K, Wilber KH. Self-report measure of financial exploitation of older adults. Gerontologist. 2010 Dec;50(6):758-73. doi: 10.1093/geront/gnq054. Epub 2010 Jul 28.
- Cancer Facts and Figures 2014. (n.d.). Retrieved May 21, 2014, from http://www.cancer.org/acs/groups/content/@research/documents/webcontent/acspc-042151.pdfLink provided by the sponsor.
- National Community Cancer Centers Program Pilot Fact Sheet, 2007-2010. (n.d.) Retrieved June 16, 2014 from http://ncccp.cancer.gov/Media/FactSheet.htmLink 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. This study is not recruiting at the moment.
Shanthi Sivendran, MD, MSCR study director
Lancaster General Ann B. Barshinger Cancer Institute
Randy Oyer, MD study director
Lancaster General Ann B. Barshinger Cancer Institute
Nik Buescher principal investigator
Lancaster General Ann B. Barshinger Cancer Institute
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 Cancer and Advanced Cancer, run by Lancaster General Hospital 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?
The sponsor lists 1 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: withdrawn, as of the sponsor's last update on 22 Apr 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Frequency of patients' ED visits and hospitalizations (time frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261051, which also lists 59 linked publications.
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 22 Apr 2016.