Histologic Response (Tumor Necrosis Rate)NCT03336554
Epigenetic Biomarker for Osteosarcoma
An observational study of Histologic Response (Tumor Necrosis Rate) and Objective Response Rate for Neoadjuvant Chemotherapy, ORR, run by Peking University People's Hospital at 1 site in China.
Trial summary
hMe-Seal is a low-input whole-genome cell-free 5hmC sequencing method based on selective chemical labeling. It uses β-glucosyltransferase (βGT) to selectively label 5hmC with a biotin via an azide-modified glucose for pull-down of 5hmC-containing DNA fragments for sequencing. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Histologic Response (Tumor Necrosis Rate), Objective Response Rate for Neoadjuvant Chemotherapy, ORR, Progression-free Survival, PFS
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Dec 2018
- How long will I take part?
- 5 Years
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Biopsy proved high-grade osteosarcoma, who should be older than 10 years and could complete routine chemo-protocol for osteosarcoma, could get enrolled.
Who may be able to join
- 1) histologically confirmed high-grade osteosarcoma;
- 2) older than 10 yrs;
- 3) initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital;
- 4) Serum samples are available;
- 5) completed neo-adjuvant chemotherapy and at least 8 cycles of adjuvant chemotherapy;
- 6) expected to live longer than 3 months with Eastern Cooperative Oncology Group performance status of 0 or 1;
- 7) acceptable hematologic, hepatic, and renal function.
Who cannot join
- 1) Serum samples are not qualified;
- 2) Patients who could not complete neo-adjuvant chemotherapy or at least 4-month adjuvant chemotherapy;
- 3) lost to follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
Tingting Ren, Ph.D., +86-13810095026, tumorcenter@163.com
About this study
Official title: Indentifying Epigenetic Biomarkers From Peripheral Blood of Osteosarcoma Patients Based on hMe-Seal Technique
hMe-Seal is a low-input whole-genome cell-free 5hmC sequencing method based on selective chemical labeling. It uses β-glucosyltransferase (βGT) to selectively label 5hmC with a biotin via an azide-modified glucose for pull-down of 5hmC-containing DNA fragments for sequencing. After selectively constructing 5hmC library, highthroughput-sequencing will be performed on an Illumina Nextseq-500 instrument. By ways of Rawdata processing, differential loci between Osteosarcoma group and control group will be detected to indentify specific epigenetic biomarkers of Osteosarcoma.
Read the detailed description
The investigator want to enroll 100 osteosarcoma participants initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital(PKUPH). All those participants will follow the chemo-protocol for osteosarcoma in PKUPH.8 ml of peripheral blood would be drawed before each cycle of chemotherapy for further analysis. After definitive surgery, participants will need to take 8ml of peripheral blood every 2 months for 6 months. A total of 6 times of blood drawing will need to be done.
In hMe-Seal approach, peripheral blood is collected into EDTA-coated Vacutainers. Plasma is collected from the blood samples after centrifugation at 1 600× g for 10 min at 4 °C and 16 000× g at 10 min at 4 °C. CfDNA is extracted using the Circulating Nucleic Acid Kit(QIAGEN). After that, cfDNA (1-10 ng) is end repaired, 3'-adenylated and ligated to DNA Barcodes using KAPA Hyper Prep Kit (Kapa Biosystems). Ligated DNA is incubated in a solution containing HEPES buffer, UDP-6-N3-Glc and βGT . After that, DBCO-PEG4-biotin is directly added to the reaction mixture. Next, DNA is purified by Micro Bio-Spin 30 Column (Bio-Rad). The purified DNA is incubated with M270 Streptavidin beads (Life Technologies) in specific buffer. The beads are subsequently undergone three 5-min washes each with four kinds of different buffers. All binding and washing are done at room temperature with gentle rotation. Beads are then resuspended in water and amplified with 16 cycles of PCR amplification. The PCR products are purified using AMPure XP beads. Pair-end 38bp sequencing is performed on the NextSeq-500 instrument.
- Conditions
- Histologic Response (Tumor Necrosis Rate), Objective Response Rate for Neoadjuvant Chemotherapy, ORR, Progression-free Survival, PFS, Overall Survival, OS
- Keywords
- osteosarcoma, epigenetic biomarker, hMe-Seal technique
- Medical subject headings
- Osteosarcoma
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 |
|---|---|---|
| observation group | One group of participants are under observation. This trial has two phase. Phase I: 40 participants will be enrolled. Only if epigenetic cfDNA library has been built, investigators would move on to Phase II. Another 60 participants will be enrolled for further analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic response
For osteosarcoma, tumor necrosis rate will be done for every participant. On pathologic examination, the surgical specimens were carefully studied and sectioned. This evaluation included establishing the gross extent of the tumor[26, 27] and noting its soft tissue component and lines of surgical resection[27]. An average of 10-20 histologic specimens were examined in each of the en bloc resections to delineate the extension of osteosarcoma up and down the marrow cavity and to study the effects of chemotherapy on the tumor (viable, partially, largely, or totally necrotic), which were then calculated as tumor necrosis rate as paper described.
Measured: 2 months
Secondary outcomes (3)
Objective Response Rate
According to RECIST 1.1, participants who meet the criteria of complete response and partial response.
Measured: 2 months
Progression-free survival
Progression-free survival (PFS) will be calculated from the start of chemotherapy to first progression.
Measured: 2 years
Overall survival
Overall survival (OS) will be calculated from the start of chemotherapy to death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Sep 2017
- Primary completion30 Oct 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Histologic Response (Tumor Necrosis Rate)Studies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Northwestern University, University of Chicago
- Responsible party
- Sponsor
- Investigators
- Wei Guo, M.D.and Ph.D., Principal investigator, Musculoskeletal Tumor Center of Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336554
- Sponsor's protocol ID
- CBTRA-02
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators of this study would like to share IPD. However other cooperative institution's consent will be needed for sharing IPD.
Publications
Bernthal NM, Federman N, Eilber FR, Nelson SD, Eckardt JJ, Eilber FC, Tap WD. Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma. Cancer. 2012 Dec 1;118(23):5888-93. doi: 10.1002/cncr.27651. Epub 2012 May 30.
PubMed 22648705Bielack S, Jurgens H, Jundt G, Kevric M, Kuhne T, Reichardt P, Zoubek A, Werner M, Winkelmann W, Kotz R. Osteosarcoma: the COSS experience. Cancer Treat Res. 2009;152:289-308. doi: 10.1007/978-1-4419-0284-9_15.
PubMed 20213397Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, van den Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier HE, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, Janeway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international, randomised controlled trial. Lancet Oncol. 2016 Oct;17(10):1396-1408. doi: 10.1016/S1470-2045(16)30214-5. Epub 2016 Aug 25.
PubMed 27569442Duchman KR, Gao Y, Miller BJ. Prognostic factors for survival in patients with high-grade osteosarcoma using the Surveillance, Epidemiology, and End Results (SEER) Program database. Cancer Epidemiol. 2015 Aug;39(4):593-9. doi: 10.1016/j.canep.2015.05.001. Epub 2015 May 20.
PubMed 26002013Tang XD, Guo W, Yang RL, Yang Y, Ji T. [Limb salvage surgery for osteosarcoma around the knee in children and adolescent patients]. Zhonghua Wai Ke Za Zhi. 2007 May 15;45(10):669-72. Chinese.
PubMed 17688817Xie L, Guo W, Tang X, Yang Y, Xu J. Effects of Arsenic Trioxide on Minor Progressive High-Grade Osteosarcoma of the Extremities Metastatic to the Lung: Results of 39 Patients Treated in a Single Institution. Case Rep Oncol. 2016 Oct 17;9(3):610-628. doi: 10.1159/000448705. eCollection 2016 Sep-Dec.
PubMed 27920692Guo W, Sun X, Ji T, Tang X. Outcome of surgical treatment of pelvic osteosarcoma. J Surg Oncol. 2012 Sep 15;106(4):406-10. doi: 10.1002/jso.23076. Epub 2012 Feb 27.
PubMed 22371155Fei D, Li Y, Zhao D, Zhao K, Dai L, Gao Z. Serum miR-9 as a prognostic biomarker in patients with osteosarcoma. J Int Med Res. 2014 Aug;42(4):932-7. doi: 10.1177/0300060514534643. Epub 2014 Jun 24.
PubMed 24962996Fu HL, Shao L, Wang Q, Jia T, Li M, Yang DP. A systematic review of p53 as a biomarker of survival in patients with osteosarcoma. Tumour Biol. 2013 Dec;34(6):3817-21. doi: 10.1007/s13277-013-0966-x. Epub 2013 Sep 7.
PubMed 24014053Bachman M, Uribe-Lewis S, Yang X, Williams M, Murrell A, Balasubramanian S. 5-Hydroxymethylcytosine is a predominantly stable DNA modification. Nat Chem. 2014 Dec;6(12):1049-55. doi: 10.1038/nchem.2064. Epub 2014 Sep 21.
PubMed 25411882Valinluck V, Tsai HH, Rogstad DK, Burdzy A, Bird A, Sowers LC. Oxidative damage to methyl-CpG sequences inhibits the binding of the methyl-CpG binding domain (MBD) of methyl-CpG binding protein 2 (MeCP2). Nucleic Acids Res. 2004 Aug 9;32(14):4100-8. doi: 10.1093/nar/gkh739. Print 2004.
PubMed 15302911Chapman CG, Mariani CJ, Wu F, Meckel K, Butun F, Chuang A, Madzo J, Bissonnette MB, Kwon JH, Godley LA. TET-catalyzed 5-hydroxymethylcytosine regulates gene expression in differentiating colonocytes and colon cancer. Sci Rep. 2015 Dec 3;5:17568. doi: 10.1038/srep17568.
PubMed 26631571
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indentifying Epigenetic Biomarkers From Peripheral Blood of Osteosarcoma Patients Based on hMe-Seal Technique
- ClinicalTrials.gov ID
- NCT03336554
- Acronym / sponsor ID
- CBTRA-02
- Conditions
- Histologic Response (Tumor Necrosis Rate), Objective Response Rate for Neoadjuvant Chemotherapy, ORR, Progression-free Survival, PFS, Overall Survival, OS
- Keywords
- osteosarcoma, epigenetic biomarker, hMe-Seal technique
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University, Northwestern University, University of Chicago
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 8 Nov 2017 (actual)
- 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.
hMe-Seal is a low-input whole-genome cell-free 5hmC sequencing method based on selective chemical labeling. It uses β-glucosyltransferase (βGT) to selectively label 5hmC with a biotin via an azide-modified glucose for pull-down of 5hmC-containing DNA fragments for sequencing. After selectively constructing 5hmC library, highthroughput-sequencing will be performed on an Illumina Nextseq-500 instrument. By ways of Rawdata processing, differential loci between Osteosarcoma group and control group will be detected to indentify specific epigenetic biomarkers of Osteosarcoma.
Detailed description
The investigator want to enroll 100 osteosarcoma participants initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital(PKUPH). All those participants will follow the chemo-protocol for osteosarcoma in PKUPH.8 ml of peripheral blood would be drawed before each cycle of chemotherapy for further analysis. After definitive surgery, participants will need to take 8ml of peripheral blood every 2 months for 6 months. A total of 6 times of blood drawing will need to be done.
In hMe-Seal approach, peripheral blood is collected into EDTA-coated Vacutainers. Plasma is collected from the blood samples after centrifugation at 1 600× g for 10 min at 4 °C and 16 000× g at 10 min at 4 °C. CfDNA is extracted using the Circulating Nucleic Acid Kit(QIAGEN). After that, cfDNA (1-10 ng) is end repaired, 3'-adenylated and ligated to DNA Barcodes using KAPA Hyper Prep Kit (Kapa Biosystems). Ligated DNA is incubated in a solution containing HEPES buffer, UDP-6-N3-Glc and βGT . After that, DBCO-PEG4-biotin is directly added to the reaction mixture. Next, DNA is purified by Micro Bio-Spin 30 Column (Bio-Rad). The purified DNA is incubated with M270 Streptavidin beads (Life Technologies) in specific buffer. The beads are subsequently undergone three 5-min washes each with four kinds of different buffers. All binding and washing are done at room temperature with gentle rotation. Beads are then resuspended in water and amplified with 16 cycles of PCR amplification. The PCR products are purified using AMPure XP beads. Pair-end 38bp sequencing is performed on the NextSeq-500 instrument.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation group | – | –One group of participants are under observation. This trial has two phase. Phase I: 40 participants will be enrolled. Only if epigenetic cfDNA library has been built, investigators would move on to Phase II. Another 60 participants will be enrolled for further analysis. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Biopsy proved high-grade osteosarcoma, who should be older than 10 years and could complete routine chemo-protocol for osteosarcoma, could get enrolled.
Key inclusion criteria (7 listed)
- 1) histologically confirmed high-grade osteosarcoma;
- 2) older than 10 yrs;
- 3) initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital;
- 4) Serum samples are available;
- 5) completed neo-adjuvant chemotherapy and at least 8 cycles of adjuvant chemotherapy;
Key exclusion criteria (3 listed)
- 1) Serum samples are not qualified;
- 2) Patients who could not complete neo-adjuvant chemotherapy or at least 4-month adjuvant chemotherapy;
- 3) lost to follow-up.
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
Histologic response
Time frame: 2 months
For osteosarcoma, tumor necrosis rate will be done for every participant. On pathologic examination, the surgical specimens were carefully studied and sectioned. This evaluation included establishing the gross extent of the tumor[26, 27] and noting its soft tissue component and lines of surgical resection[27]. An average of 10-20 histologic specimens were examined in each of the en bloc resections to delineate the extension of osteosarcoma up and down the marrow cavity and to study the effects of chemotherapy on the tumor (viable, partially, largely, or totally necrotic), which were then calculated as tumor necrosis rate as paper described.
3 secondary outcomes
Objective Response Rate
Time frame: 2 months
Progression-free survival
Time frame: 2 years
Overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Background: PubMed 22648705Bernthal NM, Federman N, Eilber FR, Nelson SD, Eckardt JJ, Eilber FC, Tap WD. Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma. Cancer. 2012 Dec 1;118(23):5888-93. doi: 10.1002/cncr.27651. Epub 2012 May 30.
- Background: PubMed 20213397Bielack S, Jurgens H, Jundt G, Kevric M, Kuhne T, Reichardt P, Zoubek A, Werner M, Winkelmann W, Kotz R. Osteosarcoma: the COSS experience. Cancer Treat Res. 2009;152:289-308. doi: 10.1007/978-1-4419-0284-9_15.
- Background: PubMed 27569442Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, van den Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier HE, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, Janeway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international, randomised controlled trial. Lancet Oncol. 2016 Oct;17(10):1396-1408. doi: 10.1016/S1470-2045(16)30214-5. Epub 2016 Aug 25.
- Background: PubMed 26002013Duchman KR, Gao Y, Miller BJ. Prognostic factors for survival in patients with high-grade osteosarcoma using the Surveillance, Epidemiology, and End Results (SEER) Program database. Cancer Epidemiol. 2015 Aug;39(4):593-9. doi: 10.1016/j.canep.2015.05.001. Epub 2015 May 20.
- Background: PubMed 17688817Tang XD, Guo W, Yang RL, Yang Y, Ji T. [Limb salvage surgery for osteosarcoma around the knee in children and adolescent patients]. Zhonghua Wai Ke Za Zhi. 2007 May 15;45(10):669-72. Chinese.
- Background: PubMed 27920692Xie L, Guo W, Tang X, Yang Y, Xu J. Effects of Arsenic Trioxide on Minor Progressive High-Grade Osteosarcoma of the Extremities Metastatic to the Lung: Results of 39 Patients Treated in a Single Institution. Case Rep Oncol. 2016 Oct 17;9(3):610-628. doi: 10.1159/000448705. eCollection 2016 Sep-Dec.
- Background: PubMed 22371155Guo W, Sun X, Ji T, Tang X. Outcome of surgical treatment of pelvic osteosarcoma. J Surg Oncol. 2012 Sep 15;106(4):406-10. doi: 10.1002/jso.23076. Epub 2012 Feb 27.
- Background: PubMed 24962996Fei D, Li Y, Zhao D, Zhao K, Dai L, Gao Z. Serum miR-9 as a prognostic biomarker in patients with osteosarcoma. J Int Med Res. 2014 Aug;42(4):932-7. doi: 10.1177/0300060514534643. Epub 2014 Jun 24.
- Background: PubMed 24014053Fu HL, Shao L, Wang Q, Jia T, Li M, Yang DP. A systematic review of p53 as a biomarker of survival in patients with osteosarcoma. Tumour Biol. 2013 Dec;34(6):3817-21. doi: 10.1007/s13277-013-0966-x. Epub 2013 Sep 7.
- Background: PubMed 25411882Bachman M, Uribe-Lewis S, Yang X, Williams M, Murrell A, Balasubramanian S. 5-Hydroxymethylcytosine is a predominantly stable DNA modification. Nat Chem. 2014 Dec;6(12):1049-55. doi: 10.1038/nchem.2064. Epub 2014 Sep 21.
- Background: PubMed 15302911Valinluck V, Tsai HH, Rogstad DK, Burdzy A, Bird A, Sowers LC. Oxidative damage to methyl-CpG sequences inhibits the binding of the methyl-CpG binding domain (MBD) of methyl-CpG binding protein 2 (MeCP2). Nucleic Acids Res. 2004 Aug 9;32(14):4100-8. doi: 10.1093/nar/gkh739. Print 2004.
- Background: PubMed 26631571Chapman CG, Mariani CJ, Wu F, Meckel K, Butun F, Chuang A, Madzo J, Bissonnette MB, Kwon JH, Godley LA. TET-catalyzed 5-hydroxymethylcytosine regulates gene expression in differentiating colonocytes and colon cancer. Sci Rep. 2015 Dec 3;5:17568. doi: 10.1038/srep17568.
- Individual participant dataSharing planned: Undecided. The investigators of this study would like to share IPD. However other cooperative institution's consent will be needed for sharing IPD.
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.
Wei Guo, M.D.and Ph.D. principal investigator
Musculoskeletal Tumor Center of Peking University People's Hospital
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 Histologic Response (Tumor Necrosis Rate) and Objective Response Rate for Neoadjuvant Chemotherapy, ORR, run by Peking University People's Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Nov 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Xie, M.D. (+86-13401044719, sweetdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic response (time frame: 2 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 NCT03336554, which also lists 12 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 13 Nov 2017.