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Breast CancerPhase 3NCT00869674

GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study

A Phase 3 study testing GeneSearch™ Breast Lymph Node (BLN) Assay in people with Breast Cancer, run by Johnson & Johnson Medical, China at 6 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this trial is to compare GeneSearch™ Breast Lymph Node (BLN) Test Kit to permanent pathological section, so as to evaluate the clinical sensitivity and specificity of GeneSearch™ Breast Lymph Node (BLN) Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
GeneSearch™ Breast Lymph Node (BLN) Assay
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
6 sitesChina
Study dates
Feb 2009to Nov 2009
Phase
Phase 3
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

Who may be able to join

  • Diagnosed previously as breast cancer
  • patient scheduled for sentinel lymph node dissection
  • 18 years or older
  • female or male, and
  • able and willing to give consent to participate in the study

Who cannot join

  • Patients taking part in other research studies that would interfere with their full participation in this study, or
  • Prior sentinel or partial axillary lymphadenectomy on the same body side

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100035

  • Southwest Hospital

    Chongqing, Sichuan, 400038

  • Guangdong General Hospital

    Guangdong, Guangdong, 510080

  • Second affiliated hospital of Zhongshan University

    Guangzhou, Guangdong

  • China Shandong Cancer hospital

    Jinan, Shandong, 250117

  • Shanghai Cancer Hospital

    Shanghai, 200032

Other trials in China

About this study

Official title: 一项比较GeneSearch 乳腺淋巴结（BLN）检测试剂盒和永久病理切片检测乳腺癌患者腋窝前哨淋巴结转移的前瞻性、多中心临床试验 A Prospective and Multi-center Clinical Trial By Comparing GeneSearch™ Breast Lymph Node (BLN) Test Kit To Permanent Pathological Section On Detecting Axillary Sentinel Lymph Node Metastases In Breast Cancer Patients

The primary objective of this trial is to compare GeneSearch™ Breast Lymph Node (BLN) Test Kit to permanent pathological section, so as to evaluate the clinical sensitivity and specificity of GeneSearch™ Breast Lymph Node (BLN) Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients.

The secondary objective of this trial is to evaluate the positive predictive value and negative predictive value of GeneSearch™ Breast Lymph Node (BLN) Test Kit when used in the detection of axillary sentinel lymph node metastases in breast cancer patients.

Prospective and multi-center clinical trial

Conditions
Breast Cancer
Being tested
GeneSearch™ Breast Lymph Node (BLN) Assay
Keywords
GeneSearch, Breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GeneSearch™ Breast Lymph Node (BLN) AssayProcedure or surgery

    Also called GeneSearch, Pathology

    Each of the sentinal lymph node will be divided in half according to cutting scheme.

    Half of the sentinal lymph node will be tested using rountine pathological method as normal practice, half of the node will have GeneSearch BLN testing.

Study groups in NCT00869674
Study groupRoleWhat they receive
Routine pathologic methodNo interventionHalf of each sentinal lymph node will have rountine pathologic examination as normal practice.
GeneSearch BLN AssayExperimentalHalf of each sentinal lymph node will have GeneSearch BLN testing.
Receives: Procedure: GeneSearch™ Breast Lymph Node (BLN) Assay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare GeneSearch™ BLN Test Kit to permanent pathological section to evaluate the clinical sensitivity and specificity of GeneSearch™ BLN Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients.

    Measured: 9 months

Secondary outcomes (1)

  1. To evaluate the positive predictive value and negative predictive value of GeneSearch™ BLN Test Kit when used in the detection of axillary sentinel lymph node metastases in breast cancer patients.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionOct 2009
  4. Study completionNov 2009

Why it stopped: Investigational products has been suspended from the US market

Resources

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 3
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00869674
Sponsor's protocol ID
OCD-200804
Other IDs
CBCSG-001a
Status last verified
Jun 2009
First submitted
25 Mar 2009
Last updated
30 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • Valagussa P, Bonadonna G, Veronesi U. Patterns of relapse and survival following radical mastectomy. Analysis of 716 consecutive patients. Cancer. 1978 Mar;41(3):1170-8. doi: 10.1002/1097-0142(197803)41:33.0.co;2-i.

    PubMed 638961

  • Fisher B, Bauer M, Wickerham DL, Redmond CK, Fisher ER, Cruz AB, Foster R, Gardner B, Lerner H, Margolese R, et al. Relation of number of positive axillary nodes to the prognosis of patients with primary breast cancer. An NSABP update. Cancer. 1983 Nov 1;52(9):1551-7. doi: 10.1002/1097-0142(19831101)52:93.0.co;2-3.

    PubMed 6352003

  • Albertini JJ, Lyman GH, Cox C, Yeatman T, Balducci L, Ku N, Shivers S, Berman C, Wells K, Rapaport D, Shons A, Horton J, Greenberg H, Nicosia S, Clark R, Cantor A, Reintgen DS. Lymphatic mapping and sentinel node biopsy in the patient with breast cancer. JAMA. 1996 Dec 11;276(22):1818-22.

    PubMed 8946902

  • Giuliano AE, Dale PS, Turner RR, Morton DL, Evans SW, Krasne DL. Improved axillary staging of breast cancer with sentinel lymphadenectomy. Ann Surg. 1995 Sep;222(3):394-9; discussion 399-401. doi: 10.1097/00000658-199509000-00016.

    PubMed 7677468

  • Morton DL. Intraoperative lymphatic mapping and sentinel lymphadenectomy: community standard care or clinical investigation? Cancer J Sci Am. 1997 Nov-Dec;3(6):328-30. No abstract available.

    PubMed 9403042

  • Yared MA, Middleton LP, Smith TL, Kim HW, Ross MI, Hunt KK, Sahin AA. Recommendations for sentinel lymph node processing in breast cancer. Am J Surg Pathol. 2002 Mar;26(3):377-82. doi: 10.1097/00000478-200203000-00013.

    PubMed 11859211

  • Schrenk P, Rieger R, Shamiyeh A, Wayand W. Morbidity following sentinel lymph node biopsy versus axillary lymph node dissection for patients with breast carcinoma. Cancer. 2000 Feb 1;88(3):608-14. doi: 10.1002/(sici)1097-0142(20000201)88:33.0.co;2-k.

    PubMed 10649254

  • Treseler PA, Tauchi PS. Pathologic analysis of the sentinel lymph node. Surg Clin North Am. 2000 Dec;80(6):1695-719. doi: 10.1016/s0039-6109(05)70256-5.

    PubMed 11140868

  • Van Diest PJ, Torrenga H, Borgstein PJ, Pijpers R, Bleichrodt RP, Rahusen FD, Meijer S. Reliability of intraoperative frozen section and imprint cytological investigation of sentinel lymph nodes in breast cancer. Histopathology. 1999 Jul;35(1):14-8. doi: 10.1046/j.1365-2559.1999.00667.x.

    PubMed 10383709

  • Veronesi U, Paganelli G, Galimberti V, Viale G, Zurrida S, Bedoni M, Costa A, de Cicco C, Geraghty JG, Luini A, Sacchini V, Veronesi P. Sentinel-node biopsy to avoid axillary dissection in breast cancer with clinically negative lymph-nodes. Lancet. 1997 Jun 28;349(9069):1864-7. doi: 10.1016/S0140-6736(97)01004-0.

    PubMed 9217757

  • Veronesi U, Paganelli G, Viale G, Galimberti V, Luini A, Zurrida S, Robertson C, Sacchini V, Veronesi P, Orvieto E, De Cicco C, Intra M, Tosi G, Scarpa D. Sentinel lymph node biopsy and axillary dissection in breast cancer: results in a large series. J Natl Cancer Inst. 1999 Feb 17;91(4):368-73. doi: 10.1093/jnci/91.4.368.

    PubMed 10050871

  • Viale G, Bosari S, Mazzarol G, Galimberti V, Luini A, Veronesi P, Paganelli G, Bedoni M, Orvieto E. Intraoperative examination of axillary sentinel lymph nodes in breast carcinoma patients. Cancer. 1999 Jun 1;85(11):2433-8.

    PubMed 10357414

  • Anderson TJ. The challenge of sentinel lymph node biopsy. Histopathology. 1999 Jul;35(1):82-4. doi: 10.1046/j.1365-2559.1999.00737.x. No abstract available.

    PubMed 10383718

  • Krag D. Current status of sentinel lymph node surgery for breast cancer. J Natl Cancer Inst. 1999 Feb 17;91(4):302-3. doi: 10.1093/jnci/91.4.302. No abstract available.

    PubMed 10050858

  • Turner RR, Hansen NM, Stern SL, Giuliano AE. Intraoperative examination of the sentinel lymph node for breast carcinoma staging. Am J Clin Pathol. 1999 Nov;112(5):627-34. doi: 10.1093/ajcp/112.5.627.

    PubMed 10549249

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GeneSearch™ Breast Lymph Node (BLN) Assay in people with Breast Cancer, run by Johnson & Johnson Medical, China at 6 sites 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 5 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: stopped early, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Investigational products has been suspended from the US market). Results are not available in the source record.

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?

To compare GeneSearch™ BLN Test Kit to permanent pathological section to evaluate the clinical sensitivity and specificity of GeneSearch™ BLN Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients. (time frame: 9 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 NCT00869674, which also lists 23 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 30 May 2013.

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