UnknownNot Applicable

Epigenetic Biomarker for Osteosarcoma

China100 participantsStarted 2017-09-01

Plain-language 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. 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.

Who can participate

Age range

10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Histologic response

Timeframe: 2 months

Trial details

NCT IDNCT03336554

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-10-30

Contact for this trial

Lu Xie, M.D.

+86-13401044719 sweetdoctor@163.com

View on ClinicalTrials.gov More Histologic Response (Tumor Necrosis Rate) trials