Intrauterine Growth RetardationNCT01177553
Randomized Clinical Trial: Expectant Management vs Laser Treatment of Monochorionic Twins With Severe Selective Intrauterine Growth Retardation and Absent or Reverse Diastolic Flow in the Umbilical Artery
A study testing selective laser photocoagulation of communicating vessels and Expected Management in people with Intrauterine Growth Retardation, run by University of South Florida at 2 sites in United States.
Trial summary
Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton pregnancies, in 9.1% of all twins and 9.9% of monochorionic twins. IUGR in monochorionic twins typically affects only one of the fetuses (selective IUGR or SIUGR). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Growth Retardation
- What is being tested?
- selective laser photocoagulation of communicating vessels and Expected Management
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational age 16--24 weeks
- Sonographic evidence of monochorionicity: single placenta, same gender, absent twin-peak sign
- Diagnosis of IUGR present in one twin (fetal weight at or below the 10th percentile for gestational age)
- Persistent absent or reverse-end diastolic flow in the umbilical artery in the SIUGR twin
- Able to provide written informed consent
Who cannot join
- Patients unwilling to participate in the study, provide consent, or to be followed up
- Presence of twin-twin transfusion syndrome (TTTS) defined as a maximum vertical pocket (MVP) of ≤2 cm in one sac and MVP of ≥8 cm in the other sac.
- Presence of major congenital anomalies (anencephaly, acardia, spina bifida) or intracranial findings in either twin: IVH, porencephalic cysts, ventriculomegaly or other findings suggestive of brain damage.
- Both twins are <10th percentile
- Diastolic flow or intermittently absent end-diastolic flow in the umbilical artery in the SIUGR twin
- Unbalanced chromosomal complement (if known).
Show all 14Show fewer
- Ruptured or detached membranes
- Placental abruption
- Chorioamnionitis
- Triplets
- Active labor
- Jehovah's witness
- Any other patient deemed inappropriate for the study by the principal investigator
- Placenta previa
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Southern California
Los Angeles, California, 90089
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Randomized Clinical Trial: Expectant Management vs. Laser Treatment of Monochorionic Twins With Severe Selective Intrauterine Growth Retardation And Absent or Reverse Diastolic Flow in the Umbilical Artery
Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton pregnancies, in 9.1% of all twins and 9.9% of monochorionic twins. IUGR in monochorionic twins typically affects only one of the fetuses (selective IUGR or SIUGR). Spontaneous demise of the SIUGR twin can occur, and may result in concomitant demise (up to 40% risk) or severe neurologic handicap (up to 30% risk) of the other twin. These complications result from exsanguination of the appropriately grown (AGA) twin into the demised SIUGR twin through placental vascular communications.
Because the adverse effects to the AGA twin of the spontaneous demise of the SIUGR twin are mediated through placental vascular anastomoses, we have proposed obliterating such anastomoses via endoscopic fetal surgery. We have developed a technique that allows us to identify the vascular anastomoses present in monochorionic placentas. Briefly, deep AV communications are identified on the surface of the placenta by noting that the terminal end of the artery of one of the fetuses does not have a corresponding returning vein to the same fetus. We have speculated that the separation of the circulations may be of benefit in monochorionic twins affected by SIUGR by preventing the adverse effects that may result from the spontaneous demise of the IUGR twin. Our goal is to evaluate with a randomized clinical trial the outcome of SIUGR managed either expectantly or with SLPCV.
Study procedures will begin with confirmation of the diagnosis and screening criteria at the Qualified Clinical Center. The patient will sign the appropriate consents and then be randomized to her treatment group. Enrollment data will be submitted to the research coordinator in Coordinating Center in Tampa. Expectant management patients will be treated by the referring physicians. Laser patients will be treated at Coordinating Center in Tampa General Hospital or qualified laser center. They may return to the referring center for follow-up. After delivery, outcome data will be sent to the research coordinator in Coordinating Center in Tampa.
- Conditions
- Intrauterine Growth Retardation
- Being tested
- selective laser photocoagulation of communicating vessels, Expected Management
- Keywords
- Intrauterine Growth Retardation in Monochorionic Twins
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective laser photocoagulation of communicating vesselsProcedure or surgery
Also called SLPCV
Antibiotic prophylaxis is initiated within an hour of surgery and continued every 8 hours through the first post-operative day. The use of these medications is safe in pregnancy in the doses and schedules outlined. Surgery will be performed under local anesthesia for the mother using 1% xylocaine with epinephrine at the trocar entry site, and IV sedation. The patient will undergo either SLPCV or UCO depending on her choice. Patients will remain hospitalized for 24-48 hours. All subjects will be monitored during their hospital stay. Any unanticipated adverse events or serious adverse events will be reported to the IRB according to IRB reporting requirements. Prior to discharge from the hospital an investigator will perform a post-procedure ultrasound to assess fetal status
Expected ManagementDevice
Also called expectant management (current accepted treatment)
Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Surgery Group | Active comparator | Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.
Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures. Receives: Procedure: selective laser photocoagulation of communicating vessels |
| Expectant Management Group | Active comparator | Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy. Receives: Device: Expected Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Effects of surgery or expectant management on postnatal neurological morbidity of the AGA baby. The primary comparison will be between SLPCV (selective laser photocoagulation of communicating vessels) and expectant management.
Measured: 6 months
Secondary outcomes (1)
Fetal/Neonatal/Infant Survival of the AGA Fetus 6 Months After Birth, Comparing the SLPCV (Selective Laser Photocoagulation of Communicating Vessels) and Expectant Management Groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startMay 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Growth RetardationStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruben A Quintero, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177553
- Sponsor's protocol ID
- IRB#105690
- Status last verified
- Feb 2013
- First submitted
- 5 Aug 2010
- Last updated
- 21 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lin CC, Santolaya-Forgas J. Current concepts of fetal growth restriction: part I. Causes, classification, and pathophysiology. Obstet Gynecol. 1998 Dec;92(6):1044-55. doi: 10.1016/s0029-7844(98)00328-7.
PubMed 9840574Ananth CV, Vintzileos AM, Shen-Schwarz S, Smulian JC, Lai YL. Standards of birth weight in twin gestations stratified by placental chorionicity. Obstet Gynecol. 1998 Jun;91(6):917-24. doi: 10.1016/s0029-7844(98)00052-0.
PubMed 9610996Hamilton EF, Platt RW, Morin L, Usher R, Kramer M. How small is too small in a twin pregnancy? Am J Obstet Gynecol. 1998 Sep;179(3 Pt 1):682-5. doi: 10.1016/s0002-9378(98)70064-x.
PubMed 9757971Dudley DK, D'Alton ME. Single fetal death in twin gestation. Semin Perinatol. 1986 Jan;10(1):65-72. No abstract available.
PubMed 3764450Fusi L, Gordon H. Twin pregnancy complicated by single intrauterine death. Problems and outcome with conservative management. Br J Obstet Gynaecol. 1990 Jun;97(6):511-6. doi: 10.1111/j.1471-0528.1990.tb02521.x.
PubMed 2198920Lin IJ, Chen CH, Wang TM, Fu LS, Chi CS. Infants of twin pregnancies with one twin demise in the uterus: a retrospective study. Acta Paediatr Taiwan. 1999 Mar-Apr;40(2):92-6.
PubMed 10910594Axt R, Hippach M, Mink D, Hendrik HJ, Ertan AK, Schmidt W. Maternal and neonatal outcome in a monochorionic twin pregnancy complicated by single intrauterine demise. Clin Exp Obstet Gynecol. 1999;26(3-4):155-7.
PubMed 10668142Petersen IR, Nyholm HC. Multiple pregnancies with single intrauterine demise. Description of twenty-eight pregnancies. Acta Obstet Gynecol Scand. 1999 Mar;78(3):202-6.
PubMed 10078581Burke MS. Single fetal demise in twin gestation. Clin Obstet Gynecol. 1990 Mar;33(1):69-78.
PubMed 2178843Saito K, Ohtsu Y, Amano K, Nishijima M. Perinatal outcome and management of single fetal death in twin pregnancy: a case series and review. J Perinat Med. 1999;27(6):473-7. doi: 10.1515/JPM.1999.063.
PubMed 10732306Nicolini U, Poblete A. Single intrauterine death in monochorionic twin pregnancies. Ultrasound Obstet Gynecol. 1999 Nov;14(5):297-301. doi: 10.1046/j.1469-0705.1999.14050297.x. No abstract available.
PubMed 10623986Kilby MD, Govind A, O'Brien PM. Outcome of twin pregnancies complicated by a single intrauterine death: a comparison with viable twin pregnancies. Obstet Gynecol. 1994 Jul;84(1):107-9.
PubMed 8008302Adegbite AL, Castille S, Ward S, Bajoria R. Neuromorbidity in preterm twins in relation to chorionicity and discordant birth weight. Am J Obstet Gynecol. 2004 Jan;190(1):156-63. doi: 10.1016/j.ajog.2003.07.004.
PubMed 14749653Karsdorp VH, van Vugt JM, van Geijn HP, Kostense PJ, Arduini D, Montenegro N, Todros T. Clinical significance of absent or reversed end diastolic velocity waveforms in umbilical artery. Lancet. 1994 Dec 17;344(8938):1664-8. doi: 10.1016/s0140-6736(94)90457-x.
PubMed 7996959Valcamonico A, Danti L, Frusca T, Soregaroli M, Zucca S, Abrami F, Tiberti A. Absent end-diastolic velocity in umbilical artery: risk of neonatal morbidity and brain damage. Am J Obstet Gynecol. 1994 Mar;170(3):796-801. doi: 10.1016/s0002-9378(94)70285-3.
PubMed 8141204
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: Expectant Management vs. Laser Treatment of Monochorionic Twins With Severe Selective Intrauterine Growth Retardation And Absent or Reverse Diastolic Flow in the Umbilical Artery
- ClinicalTrials.gov ID
- NCT01177553
- Acronym / sponsor ID
- IRB#105690
- Conditions
- Intrauterine Growth Retardation
- Keywords
- Intrauterine Growth Retardation in Monochorionic Twins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Posted 12 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton pregnancies, in 9.1% of all twins and 9.9% of monochorionic twins. IUGR in monochorionic twins typically affects only one of the fetuses (selective IUGR or SIUGR). Spontaneous demise of the SIUGR twin can occur, and may result in concomitant demise (up to 40% risk) or severe neurologic handicap (up to 30% risk) of the other twin. These complications result from exsanguination of the appropriately grown (AGA) twin into the demised SIUGR twin through placental vascular communications.
Because the adverse effects to the AGA twin of the spontaneous demise of the SIUGR twin are mediated through placental vascular anastomoses, we have proposed obliterating such anastomoses via endoscopic fetal surgery. We have developed a technique that allows us to identify the vascular anastomoses present in monochorionic placentas. Briefly, deep AV communications are identified on the surface of the placenta by noting that the terminal end of the artery of one of the fetuses does not have a corresponding returning vein to the same fetus. We have speculated that the separation of the circulations may be of benefit in monochorionic twins affected by SIUGR by preventing the adverse effects that may result from the spontaneous demise of the IUGR twin. Our goal is to evaluate with a randomized clinical trial the outcome of SIUGR managed either expectantly or with SLPCV.
Study procedures will begin with confirmation of the diagnosis and screening criteria at the Qualified Clinical Center. The patient will sign the appropriate consents and then be randomized to her treatment group. Enrollment data will be submitted to the research coordinator in Coordinating Center in Tampa. Expectant management patients will be treated by the referring physicians. Laser patients will be treated at Coordinating Center in Tampa General Hospital or qualified laser center. They may return to the referring center for follow-up. After delivery, outcome data will be sent to the research coordinator in Coordinating Center in Tampa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery Group | Active comparator | Procedure: selective laser photocoagulation of communicating vesselsPatients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form. Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures. |
| Expectant Management Group | Active comparator | Device: Expected ManagementPatients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gestational age 16--24 weeks
- Sonographic evidence of monochorionicity: single placenta, same gender, absent twin-peak sign
- Diagnosis of IUGR present in one twin (fetal weight at or below the 10th percentile for gestational age)
- Persistent absent or reverse-end diastolic flow in the umbilical artery in the SIUGR twin
- Able to provide written informed consent
Key exclusion criteria (14 listed)
- Patients unwilling to participate in the study, provide consent, or to be followed up
- Presence of twin-twin transfusion syndrome (TTTS) defined as a maximum vertical pocket (MVP) of ≤2 cm in one sac and MVP of ≥8 cm in the other sac.
- Presence of major congenital anomalies (anencephaly, acardia, spina bifida) or intracranial findings in either twin: IVH, porencephalic cysts, ventriculomegaly or other findings suggestive of brain damage.
- Both twins are <10th percentile
- Diastolic flow or intermittently absent end-diastolic flow in the umbilical artery in the SIUGR twin
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 |
|---|---|---|
| selective laser photocoagulation of communicating vesselsAlso: SLPCVAntibiotic prophylaxis is initiated within an hour of surgery and continued every 8 hours through the first post-operative day. The use of these medications is safe in pregnancy in the doses and schedules outlined. Surgery will be performed under local anesthesia for the mother using 1% xylocaine with epinephrine at the trocar entry site, and IV sedation. The patient will undergo either SLPCV or UCO depending on her choice. Patients will remain hospitalized for 24-48 hours. All subjects will be monitored during their hospital stay. Any unanticipated adverse events or serious adverse events will be reported to the IRB according to IRB reporting requirements. Prior to discharge from the hospital an investigator will perform a post-procedure ultrasound to assess fetal status | Procedure or surgery | Surgery Group |
| Expected ManagementAlso: expectant management (current accepted treatment)Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy. | Device | Expectant Management Group |
Primary outcome
Survival
Time frame: 6 months
Effects of surgery or expectant management on postnatal neurological morbidity of the AGA baby. The primary comparison will be between SLPCV (selective laser photocoagulation of communicating vessels) and expectant management.
1 secondary outcome
Fetal/Neonatal/Infant Survival of the AGA Fetus 6 Months After Birth, Comparing the SLPCV (Selective Laser Photocoagulation of Communicating Vessels) and Expectant Management Groups.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9840574Lin CC, Santolaya-Forgas J. Current concepts of fetal growth restriction: part I. Causes, classification, and pathophysiology. Obstet Gynecol. 1998 Dec;92(6):1044-55. doi: 10.1016/s0029-7844(98)00328-7.
- Background: PubMed 9610996Ananth CV, Vintzileos AM, Shen-Schwarz S, Smulian JC, Lai YL. Standards of birth weight in twin gestations stratified by placental chorionicity. Obstet Gynecol. 1998 Jun;91(6):917-24. doi: 10.1016/s0029-7844(98)00052-0.
- Background: PubMed 9757971Hamilton EF, Platt RW, Morin L, Usher R, Kramer M. How small is too small in a twin pregnancy? Am J Obstet Gynecol. 1998 Sep;179(3 Pt 1):682-5. doi: 10.1016/s0002-9378(98)70064-x.
- Background: PubMed 3764450Dudley DK, D'Alton ME. Single fetal death in twin gestation. Semin Perinatol. 1986 Jan;10(1):65-72. No abstract available.
- Background: PubMed 2198920Fusi L, Gordon H. Twin pregnancy complicated by single intrauterine death. Problems and outcome with conservative management. Br J Obstet Gynaecol. 1990 Jun;97(6):511-6. doi: 10.1111/j.1471-0528.1990.tb02521.x.
- Background: PubMed 10910594Lin IJ, Chen CH, Wang TM, Fu LS, Chi CS. Infants of twin pregnancies with one twin demise in the uterus: a retrospective study. Acta Paediatr Taiwan. 1999 Mar-Apr;40(2):92-6.
- Background: PubMed 10668142Axt R, Hippach M, Mink D, Hendrik HJ, Ertan AK, Schmidt W. Maternal and neonatal outcome in a monochorionic twin pregnancy complicated by single intrauterine demise. Clin Exp Obstet Gynecol. 1999;26(3-4):155-7.
- Background: PubMed 10078581Petersen IR, Nyholm HC. Multiple pregnancies with single intrauterine demise. Description of twenty-eight pregnancies. Acta Obstet Gynecol Scand. 1999 Mar;78(3):202-6.
- Background: PubMed 2178843Burke MS. Single fetal demise in twin gestation. Clin Obstet Gynecol. 1990 Mar;33(1):69-78.
- Background: PubMed 10732306Saito K, Ohtsu Y, Amano K, Nishijima M. Perinatal outcome and management of single fetal death in twin pregnancy: a case series and review. J Perinat Med. 1999;27(6):473-7. doi: 10.1515/JPM.1999.063.
- Background: PubMed 10623986Nicolini U, Poblete A. Single intrauterine death in monochorionic twin pregnancies. Ultrasound Obstet Gynecol. 1999 Nov;14(5):297-301. doi: 10.1046/j.1469-0705.1999.14050297.x. No abstract available.
- Background: PubMed 8008302Kilby MD, Govind A, O'Brien PM. Outcome of twin pregnancies complicated by a single intrauterine death: a comparison with viable twin pregnancies. Obstet Gynecol. 1994 Jul;84(1):107-9.
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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.
Ruben A Quintero, MD principal investigator
University of South Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selective laser photocoagulation of communicating vessels and Expected Management in people with Intrauterine Growth Retardation, run by University of South Florida at 2 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 5 inclusion and 14 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 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 12 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival (time frame: 6 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 NCT01177553, which also lists 34 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 21 Feb 2013.