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Status unknownNCT02797652Updated Jun 14, 2016

Clinical Application of CTDNA in Operable Breast Cancer Patients

An observational study in Breast Cancer, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-06-14.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 70 Years
Sex
Female
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Study summary

Our study aims to evaluate the possibility of clinical application of CTDNA detection in samples or peripheral blood of breast cancer patients, so as to act as the new techniques or indicators of early diagnosis, therapy efficiency, or postoperative surveillance of breast cancer.

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Conditions studied

  • Breast Cancer

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Keywords

  • Breast cancer
  • ctDNA
  • Neoadjuvant chemotherapy
  • Adjuvant chemotherapy
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 60 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Operable breast cancer patients who need chemotherapy before or after surgery.

Inclusion criteria

  1. Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
  2. Age of at least 18 and at most 70 years.
  3. Performance status (Karnofsky-Index) >80%.
  4. Chemotherapy is necessary before or after surgery.
  5. No clinical evidence of local recurrence or distant metastases.
  6. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
  7. Life expectancy of at least 2 years, disregarding the diagnosis of cancer.
  8. Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
  9. Patients must be available for and compliant to treatment and follow-up.
  10. Patients registered on this trial must be treated and followed up at the participating center.

Exclusion criteria

Exclusion Criteria:

  1. Known hypersensitivity reaction to the investigational compounds or incorporated substances.
  2. Local recurrence and/or metastasis of breast cancer.
  3. No need of chemotherapy.

  4. Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.

    Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)

  5. Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias
  6. Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
  7. Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
  8. Males.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Neoadjuvant chemotherapy

    ctDNA of operable breast cancer patients with neoadjuvant chemotherapy before surgery in different periods: before neo-chemotherapy, during neo-chemotherapy, on surgery day, after surgery and follow-up time.

    Procedure: Neoadjuvant chemotherapy before surgery

  • Surgery

    ctDNA of operable breast cancer patients with surgery followed by adjuvant chemotherapy in different periods: on surgery day, after surgery, before adjuvant chemotherapy, during adjuvant chemotherapy, and follow-up time.

    Procedure: Surgery followed by adjuvant chemotherapy

Interventions

  • ProcedureNeoadjuvant chemotherapy before surgery

    The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.

  • ProcedureSurgery followed by adjuvant chemotherapy

    The operable breast cancer patients takes surgery followed by adjuvant chemotherapy.

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What researchers measure

Primary outcomes

  1. The number of ctDNA copies per milliliter in patients' peripheral blood

    The number of ctDNA copies per milliliter in patients' peripheral blood of neoadjuvant chemotherapy group and surgery group in different periods

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    • Qiang Sun, Doctor · Contact · sunqiangpumc@163.com · 86-010-69152701
    • Li Peng, Doctor · Contact · pl226@sina.com · 86-010-69152701
    • Yidong Zhou, Doctor · Principal investigator
    • Li Peng, Doctor · Sub investigator
    Recruiting
08

References and documents

Publications

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. PubMed 26808342 ↗
  • Crowley E, Di Nicolantonio F, Loupakis F, Bardelli A. Liquid biopsy: monitoring cancer-genetics in the blood. Nat Rev Clin Oncol. 2013 Aug;10(8):472-84. doi: 10.1038/nrclinonc.2013.110. Epub 2013 Jul 9. PubMed 23836314 ↗
  • Dawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13. PubMed 23484797 ↗
  • Garcia-Murillas I, Schiavon G, Weigelt B, Ng C, Hrebien S, Cutts RJ, Cheang M, Osin P, Nerurkar A, Kozarewa I, Garrido JA, Dowsett M, Reis-Filho JS, Smith IE, Turner NC. Mutation tracking in circulating tumor DNA predicts relapse in early breast cancer. Sci Transl Med. 2015 Aug 26;7(302):302ra133. doi: 10.1126/scitranslmed.aab0021. PubMed 26311728 ↗
  • Reinert T, Scholer LV, Thomsen R, Tobiasen H, Vang S, Nordentoft I, Lamy P, Kannerup AS, Mortensen FV, Stribolt K, Hamilton-Dutoit S, Nielsen HJ, Laurberg S, Pallisgaard N, Pedersen JS, Orntoft TF, Andersen CL. Analysis of circulating tumour DNA to monitor disease burden following colorectal cancer surgery. Gut. 2016 Apr;65(4):625-34. doi: 10.1136/gutjnl-2014-308859. Epub 2015 Feb 4. PubMed 25654990 ↗
  • Zill OA, Greene C, Sebisanovic D, Siew LM, Leng J, Vu M, Hendifar AE, Wang Z, Atreya CE, Kelley RK, Van Loon K, Ko AH, Tempero MA, Bivona TG, Munster PN, Talasaz A, Collisson EA. Cell-Free DNA Next-Generation Sequencing in Pancreatobiliary Carcinomas. Cancer Discov. 2015 Oct;5(10):1040-8. doi: 10.1158/2159-8290.CD-15-0274. Epub 2015 Jun 24. PubMed 26109333 ↗
  • Zhou Y, Xu Y, Wang C, Gong Y, Zhang Y, Yao R, Li P, Zhu X, Bai J, Guan Y, Xia X, Yang L, Yi X, Sun Q. Serial circulating tumor DNA identification associated with the efficacy and prognosis of neoadjuvant chemotherapy in breast cancer. Breast Cancer Res Treat. 2021 Aug;188(3):661-673. doi: 10.1007/s10549-021-06247-y. Epub 2021 May 18. PubMed 34003409 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02797652
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Qiang SUN (Professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Jun 13, 2016
Start date
May 2016
Primary completion
Apr 2018 (estimated)
Last update
Jun 14, 2016

Study contacts

Qiang Sun, Doctor
Contact
sunqiangpumc@sina.com
86-010-69152701
Li Peng, Doctor
Contact
pl226@sina.com
86-010-69152701
Qiang Sun, Doctor
principal investigator · Peking Union Medical College Hospital
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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