NCT03635216

Brief Summary

Sonic hedgehog (Shh) signaling, including Gli1, is critical to treatment resistance. For optimizing cervical cancer treatment, the pathological prognostic factors determine whether to administer adjuvant therapy. However, the majority of clinical results was from squamous cell carcinoma, rendering conclusions for adenocarcinoma less convincing. We aimed to examine the role of Shh signaling in long-term clinical outcomes of cervical adenocarcinoma after receiving major surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

Same day

First QC Date

August 15, 2018

Last Update Submit

August 15, 2018

Conditions

Uterine Cervical Neoplasms

Keywords

Cervical cancerBiomarkerRecurrence

Outcome Measures

Primary Outcomes (1)

  • Shh, Ptch-1, Smo and Gli1

    Sonic hedgehog (Shh) signaling, including Gli1, is critical to treatment resistance. to examine the role of Shh signaling in long-term clinical outcomes of cervical adenocarcinoma after receiving major surgery

    1987-2002

Secondary Outcomes (3)

  • overall survival

    1987-2002

  • progression free survival

    1987-2002

  • local recurrence

    1987-2002

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailscervical cancer only occurring in women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cervical adenocarcinoma that received major surgery. External beam radiotherapy with 50-60 Gy followed by brachytherapy with 30 Gy was delivered with or without concurrent weekly cisplatin 40 mg/m2.

You may qualify if:

  • cervical cancer patients
  • performance status Eastern Cooperative Oncology Group 0-1 (ECOG 0-1)

You may not qualify if:

  • non-other cancer previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

Related Publications (3)

  • Hong JH, Tsai CS, Chang JT, Wang CC, Lai CH, Lee SP, Tseng CJ, Chang TC, Tang SG. The prognostic significance of pre- and posttreatment SCC levels in patients with squamous cell carcinoma of the cervix treated by radiotherapy. Int J Radiat Oncol Biol Phys. 1998 Jul 1;41(4):823-30. doi: 10.1016/s0360-3016(98)00147-3.

    PMID: 9652844BACKGROUND

  • Ogino I, Nakayama H, Kitamura T, Okamoto N, Inoue T. The curative role of radiotherapy in patients with isolated para-aortic node recurrence from cervical cancer and value of squamous cell carcinoma antigen for early detection. Int J Gynecol Cancer. 2005 Jul-Aug;15(4):630-8. doi: 10.1111/j.1525-1438.2005.00119.x.

    PMID: 16014117BACKGROUND

  • Huang EY, Wang CJ, Chen HC, Fang FM, Huang YJ, Wang CY, Hsu HC. Multivariate analysis of para-aortic lymph node recurrence after definitive radiotherapy for stage IB-IVA squamous cell carcinoma of uterine cervix. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):834-42. doi: 10.1016/j.ijrobp.2008.01.035. Epub 2008 Apr 24.

    PMID: 18439764BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

cervical cancer specimen for immunohistochemistry staining

MeSH Terms

Conditions

Uterine Cervical NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yu-Jen Chen, MD

    Department of Radiation Oncology, MacKay Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 17, 2018

Study Start

May 21, 2018

Primary Completion

May 21, 2018

Study Completion

May 20, 2023

Last Updated

August 17, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)